Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-24 @ 9:09 PM
Study NCT ID:
NCT05014204
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2021-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'csorli@endogenex.com', 'phone': '(763) 251-6820', 'title': 'Chris Sorli, CMO', 'organization': 'Endogenex'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This pilot study was designed to assesses the initial safety of the Endogenex device in participants with type 2 diabetes. Due to the small sample size, no formal hypothesis testing was performed. Descriptive statistics are reported using mean and standard deviations.'}}, 'adverseEventsModule': {'timeFrame': 'Enrollment through study completion at 48 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Interventional Arm- Endogenex (PEF) Treatment', 'description': 'Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 19, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Upper abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'CGM application site bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gastroesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hemmorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Limb Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lip Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Meniscus Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Musculoskeletal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nasopharyngititis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Esophagititis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pharyngititis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Plantar Facititis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Procedural Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Rib Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Skin Papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ulcerative Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vomitting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lip Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Orthostatic Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Nephrolithiasis', 'notes': 'Not device-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute cholecystitis', 'notes': 'Not device-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cholecystectomy', 'notes': 'Not device-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Malignant Melanoma', 'notes': 'Not device-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Colon Adenoma', 'notes': 'Not device-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants Experiencing Device- or Procedure-Related Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm- Endogenex (PEF) Treatment', 'description': 'Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks post-procedure', 'description': 'Number of participants experiencing device- or procedure-related serious adverse events (SAE)', 'unitOfMeasure': 'Number of Participants with related SAE', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary endpoint was performed at 12 weeks. At the 12 weeks, data from all 20 participants were available. Two participants exited the study at the 24 week visit, resulting in the 18 participants completing the study at 48 weeks.'}, {'type': 'SECONDARY', 'title': 'Mean HbA1c by Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm- Endogenex (PEF) Treatment', 'description': 'Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.'}], 'classes': [{'title': 'Mean HbA1c at Week 4 Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Mean HbA1c at Week 12 Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Mean HbA1c at Week 24 Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Mean HbA1c at Week 36 Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Mean HbA1c at Week 48 Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 4,12, 24, and 48 Weeks Post Procedure', 'description': 'Mean HbA1c by Post Procedure Follow-up Visits', 'unitOfMeasure': 'HbA1c %', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants were exited from the study by 24 weeks'}, {'type': 'SECONDARY', 'title': 'Mean Fasting Plasma Glucose (FPG) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm- Endogenex (PEF) Treatment', 'description': 'Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.'}], 'classes': [{'title': 'Mean FPG at Week 4 post procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '140.1', 'spread': '28.6', 'groupId': 'OG000'}]}]}, {'title': 'Mean FPG at Week 12 post procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '155.7', 'spread': '28.8', 'groupId': 'OG000'}]}]}, {'title': 'Mean FPG at Week 24 post procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '155.9', 'spread': '42.7', 'groupId': 'OG000'}]}]}, {'title': 'Mean FPG at Week 36 post procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '150.8', 'spread': '24.2', 'groupId': 'OG000'}]}]}, {'title': 'Mean FPG at Week 48 at post procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '161.6', 'spread': '37.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up at 4,12, 24, 36, and 48 weeks post procedure', 'description': 'Mean Fasting Plasma Glucose (FPG) at Post Procedure Follow-up Visit', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants were exited from the study by 24 weeks.'}, {'type': 'SECONDARY', 'title': 'Mean Weight by Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm- Endogenex (PEF) Treatment', 'description': 'Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.'}], 'classes': [{'title': 'Mean Weight at Week 4 Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '215.6', 'spread': '38.1', 'groupId': 'OG000'}]}]}, {'title': 'Mean Weight at Week 12 Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '209.3', 'spread': '36.1', 'groupId': 'OG000'}]}]}, {'title': 'Mean Weight at Week 24 Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '214.9', 'spread': '40.3', 'groupId': 'OG000'}]}]}, {'title': 'Mean Weight at Week 36 Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '213.3', 'spread': '41.1', 'groupId': 'OG000'}]}]}, {'title': 'Mean Weight at Week 48 Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '217.8', 'spread': '41.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up at 4,12, 24, 36, and 48 weeks post procedure', 'description': 'Mean weight by Post Procedure Follow-up Visit', 'unitOfMeasure': 'lbs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants were exited by 24 Weeks'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm- Endogenex (PEF) Treatment', 'description': 'Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the time of procedure', 'description': 'Percentage of participants with successful DMR procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Procedural Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm- Endogenex (PEF) Treatment', 'description': 'Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.9', 'spread': '20.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the time of procedure', 'description': 'Time between catheter insertion to catheter removal', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interventional Arm- Endogenex (PEF) Treatment', 'description': 'Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '2 participants were exited from the study at 24 weeks after completing the primary safety endpoint', 'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from 3 study sites in the US. Twenty participants were enrolled (i.e. received Endogenex treatment). Two participants did not complete the study due to patient withdrawal and physician withdrawal to relocation.', 'preAssignmentDetails': "Pre-assignment did not occur in this study. All participants that met inclusion criteria and none of the exclusion criteria received treatment with the Endogenex device. At the time of the procedure, a screening endoscopy was performed on all participants to visually confirm the suitability of GI anatomy and excluding any participants with anatomy that met exclusion or preclude operator's ability to safely complete the treatment."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Interventional Arm- Endogenex (PEF) Treatment', 'description': 'Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '54.4', 'spread': '7.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Mean Age (years)', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HbA1c (%)', 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '0.54', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes (years)', 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI (kg/m²)', 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'spread': '4.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (lbs)', 'classes': [{'categories': [{'measurements': [{'value': '224', 'spread': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'lbs', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-03', 'size': 3217511, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-08T22:30', 'hasProtocol': True}, {'date': '2024-09-09', 'size': 1351929, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-08T20:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2021-08-13', 'resultsFirstSubmitDate': '2025-10-08', 'studyFirstSubmitQcDate': '2021-08-13', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-18', 'studyFirstPostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Procedural Success', 'timeFrame': 'At the time of procedure', 'description': 'Percentage of participants with successful DMR procedure'}, {'measure': 'Procedural Time', 'timeFrame': 'At the time of procedure', 'description': 'Time between catheter insertion to catheter removal'}], 'primaryOutcomes': [{'measure': 'Participants Experiencing Device- or Procedure-Related Serious Adverse Events (SAE)', 'timeFrame': '12 weeks post-procedure', 'description': 'Number of participants experiencing device- or procedure-related serious adverse events (SAE)'}], 'secondaryOutcomes': [{'measure': 'Mean HbA1c by Follow-up Visit', 'timeFrame': 'at 4,12, 24, and 48 Weeks Post Procedure', 'description': 'Mean HbA1c by Post Procedure Follow-up Visits'}, {'measure': 'Mean Fasting Plasma Glucose (FPG) by Visit', 'timeFrame': 'Follow-up at 4,12, 24, 36, and 48 weeks post procedure', 'description': 'Mean Fasting Plasma Glucose (FPG) at Post Procedure Follow-up Visit'}, {'measure': 'Mean Weight by Follow-up Visit', 'timeFrame': 'Follow-up at 4,12, 24, 36, and 48 weeks post procedure', 'description': 'Mean weight by Post Procedure Follow-up Visit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Endoscopy', 'type 2 diabetes'], 'conditions': ['Diabetes', 'Diabetes Type 2', 'Diabetes Mellitus, Type 2', 'Glucose Metabolism Disorders', 'Metabolic Disease', 'Endocrine System Diseases', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, open-label study to assess the feasibility and preliminary safety of the Endogenex Device for endoscopic duodenal mucosal regeneration in patients with type 2 Diabetes inadequately controlled on 2-3 non-insulin glucose-lowering medications.', 'detailedDescription': 'Individuals who sign the informed consent will be screened for study eligibility. Eligible participants will be treated with the Endogenex procedure and followed up for 48 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 22- 65 years of age\n2. Current diagnosis of T2D\n3. History of T2D for at least 3 years and less than or equal to 10 years\n4. HbA1C of 7.5-10.0%, inclusive\n5. BMI 24-40 kg/m2, inclusive\n6. On two to three non-insulin glucose lowering mediations, with one at maximum tolerated dose and another at half-maximum dose at least, with no changes in medication for at least 12 weeks prior to baseline visit prior to baseline visit\n7. History of failed attempt to reach glycemic goal by lifestyle modifications\n8. Weight stability (defined as a \\< 5% change in body weight) for at least 12 weeks prior to the screening visit\n9. Agree not to donate blood during participation in the study.\n10. Able to comply with study requirements and understand and sign the Informed Consent Form\n11. Women of childbearing potential must be using an acceptable method of contraception throughout the study\n12. Willing and able to use CGM for the duration of the study and comply with study visits and study tasks as required per protocol.\n13. Proof of COVID 19 vaccination.\n\nExclusion Criteria:\n\n1. Diagnosed with type 1 diabetes\n2. History of diabetic ketoacidosis or hyperosmolar nonketotic coma\n3. Probable insulin production failure, defined as overnight fasting C-peptide serum \\<1 ng/mL (333pmol/l).\n4. Previous use of any types of insulin for \\>1 month (at any time, except for treatment of gestational diabetes) in last 2 years.\n5. Current use of insulin\n6. Hypoglycemia unawareness\n7. History of ≥1 severe hypoglycemia episode (defined by needing for third-party assistance) in past 6 months from the screening visit\n8. Known autoimmune disease, as evidenced by a positive anti-glutamic acid decarboxylase (GAD) test, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder. (Participants with adequately controlled primary hypothyroidism may be included).\n9. Previous GI surgery that has changed GI anatomy or could limit treatment of the duodenum, such as Billroth 2, Roux-en-Y gastric bypass, gastric band or other similar procedures or conditions.\n10. Known history of a structural or functional disorder of the upper GI tract that may impede passage of the device through the upper GI tract or increase risk of tissue damage during an endoscopic procedure, including esophagitis, stricture/stenosis, varices, diverticula, or other disorder of the esophagus, stomach and duodenum.\n11. Active H. pylori infection (Participants with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen)\n12. History of, or gastrointestinal symptoms suggestive of gastroparesis.\n13. Acute gastrointestinal illness in the previous 7 days\n14. Known history of irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease and Celiac disease\n15. History of chronic or acute pancreatitis.\n16. Known active hepatitis or active liver disease other than NASH/NAFLD.\n17. Alcoholic liver disease, as indicated by ANI \\> 0\n18. Current use of anticoagulation therapy (such as warfarin) that cannot be discontinued for 7 days before and 14 days after the procedure.\n19. Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 14 days before and 14 days after the procedure.\n20. Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during treatment through 4 weeks following the procedure. Use of acetaminophen and low dose aspirin is allowed.\n21. Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 12 weeks prior to the baseline visit.\n22. Use of drugs known to affect GI motility (e.g. Metoclopramide)\n23. Use of weight loss medications such as Meridia, Xenical, Phentermine or over-the-counter weight loss medications (prescription medication)\n24. Currently taking, or unable to stop taking dietary supplements or herbal agents, including vitamin C or multivitamins containing vitamin C at \\>500 mg per day, multivitamins containing biotin (vitamin B7), and supplements for hair, skin, and nail growth. Multivitamins not containing biotin are permitted.\n25. Persistent anemia, defined as hemoglobin \\<10 g/dL.\n26. Known history of hemoglobinopathy.\n27. Known history of blood donation or transfusion within 3 months prior to the Screening Visit.\n28. Known history of cardiac arrythmia\n29. Significant cardiovascular disease, including known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack, or stroke within 6 months prior to the Screening Visit.\n30. Estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73m2 (estimated by MDRD).\n31. Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the participant a poor candidate for clinical trial participation in the opinion of the investigator.\n32. History of secondary hypothyroidism or inadequately controlled primary hypothyroidism (TSH value outside the normal range at screening)\n33. With any implanted electronic devices or duodenal metallic implants\n34. Not a candidate for upper GI endoscopy or general anesthesia.\n35. Active illicit substance abuse or alcoholism (\\>2 drinks/day regularly)\n36. Active malignancy within the last 5 years (excluding non-melanoma skin cancers)\n37. Women breastfeeding\n38. Participating in another ongoing clinical trial of an investigational drug or device.\n39. Any other mental or physical condition which, in the opinion of the study investigator, makes the participant a poor candidate for clinical trial participation.\n40. Critically ill or has a life expectancy \\<3 years\n\n Additional exclusion criteria to be confirmed during the screening process:\n41. HbA1c \\< 7.5% or \\> 10% at baseline visit\n42. Any severe hypoglycemic event since the screening visit\n43. CGM readings \\<54 mg/dl in more than 1% of time by CGM since the screening visit\n44. CGM readings \\> 360 mg/dL in more than 1% of time\n45. Mean of 3 separate blood pressure measurements \\>180 mmHg (systolic) or \\>100 mmHg (diastolic)\n46. Women of child-bearing potential with a positive urine pregnancy test at baseline visit\n47. LA Grade C or greater esophagitis on endoscopy\n48. Abnormalities of the GI tract preventing endoscopic access to the duodenum\n49. Anatomic abnormalities in the duodenum that would preclude the completion of the treatment procedure, including tortuous anatomy\n50. Endoscopic observation of upper gastrointestinal abnormality such as ulcers, polyps, varices, strictures, congenital or intestinal telangiectasia\n51. Any other anatomical or endoscopic abnormalities/characteristics that, in the opinion of the investigator, would preclude safe use of the investigational device or procedure"}, 'identificationModule': {'nctId': 'NCT05014204', 'acronym': 'REGENT-1-US', 'briefTitle': 'Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Endogenex, Inc.'}, 'officialTitle': 'Safety and Feasibility of Endoscopic Application of a Novel Therapy for Duodenal Mucosal Regeneration in the Treatment of Type II Diabetes', 'orgStudyIdInfo': {'id': '346'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional', 'description': 'All eligible patients will receive the endoscopic Endogenex procedure.', 'interventionNames': ['Device: The Endogenex Device']}], 'interventions': [{'name': 'The Endogenex Device', 'type': 'DEVICE', 'description': 'The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field. The Endogenex procedure is a non-surgical, endoscopic procedure.', 'armGroupLabels': ['Interventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '56441', 'city': 'Crosby', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Cuyuna Regional Medical Center', 'geoPoint': {'lat': 46.48218, 'lon': -93.95776}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Daniel DeMarco, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Baylor Scott & White'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endogenex, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}