Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-24 @ 5:42 PM
Study NCT ID:
NCT06661668
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2024-01-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2024-01-29', 'studyFirstSubmitQcDate': '2024-10-25', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms', 'timeFrame': '5 years', 'description': 'Symptom severity/Improvement of symptoms pre-/post gastric pacemaker implantation using the standardized Gastroparesis Cardinal Symptom Index (GCSI). The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). A total score of 45 can be achieved. A high score indicates more severe symptoms.'}, {'measure': 'Health-related quality of life', 'timeFrame': '5 years', 'description': 'Health-related quality of life pre-/post gastric pacemaker implantation using the GIQLI questionnaire (Gastrointestinal Quality of Life Index). GIQLI is a validated instrument to assess HRQoL among patients with gastrointestinal disorders. The questionnaire consists of 36 questions and is subdivided into five subcategories (symptoms, emotion, physical function, social function, and medical treatment). Total scores between 0 and 144 can be achieved. Respective total scores for the specific subcategories are symptoms=76, emotions=20, physical=28, and social=20. Higher scores represent a higher HRQoL.17'}], 'secondaryOutcomes': [{'measure': 'Hospital admission', 'timeFrame': '5 years', 'description': 'Frequency of hospital admission for further treatment pre/post gastric pacemaker implantation'}, {'measure': 'Perioperative complication rate', 'timeFrame': '1 year', 'description': 'Perioperative complications such as wound infection, pain, dysfunctional device'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Gastroparesis', 'Gastric pacemaker'], 'conditions': ['Gastroparesis', 'Gastroparesis Postoperative', 'Gastroparesis Nondiabetic', 'Gastroparesis With Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': "Gastroparesis is a burdensome condition that is caused by abnormal motor function of the stomach that results in delayed gastric emptying. It typically manifests with bloating, nausea, vomiting, abdominal pain, and even excessive weight loss and dehydration. The most common causes of gastroparesis are idiopathic, diabetic, medication-induced or iatrogenic (postsurgical) gastroparesis.\n\nImplantation of a gastric neurostimulation device is a surgical option to improve gastric emptying in patients with medication-refractory gastroparesis. Enterra® system is a gastric electrical stimulation that sends mild pulses through leads implanted in the stomach wall that stimulate gastric smooth muscles and nerves in order to improve symptoms and quality of life.\n\nAim of the investogators' registry trial is to evaluate the feasibility and efficacy of laparoscopic gastric pacemaker implantation for electrical stimulation (Enterra® system). Primary endpoints of the study are symptom severity, health-related quality of life, and frequency of hospitalization before and after pacemaker implantation, perioperative complication rate, and cost effectiveness.", 'detailedDescription': 'Gastroparesis is a burdensome condition that is caused by abnormal motor function of the stomach that results in delayed gastric emptying. It typically manifests with bloating, nausea, vomiting, abdominal pain, and even excessive weight loss and dehydration. The most common causes of gastroparesis are idiopathic, diabetic, medication-induced or iatrogenic (postsurgical) gastroparesis.\n\nAfter ruling out mechanical obstruction as an underlying cause of gastroparesis using endoscopy or computed tomography, further assessment includes gastric emptying studies by scintigraphy to confirm the presence of delayed gastric emptying. Severity of symptoms and impact on health-related quality of life can be assessed using the Gastroparesis Cardinal Symptom Index (GCSI) and Gastrointestinal Quality of Life Index (GIQLI).\n\nManagement of gastroparesis includes assessment of nutritional status, correction of fluid, electrolytes and nutritional deficiencies, symptomatic therapy, management of the underlying cause of gastroparesis, and improvement of gastric emptying. Implantation of a gastric neurostimulation device is a surgical option to improve gastric emptying in patients with medication-refractory gastroparesis. Enterra® system is a gastric electrical stimulation that sends mild pulses through leads implanted in the stomach wall that stimulate gastric smooth muscles and nerves in order to improve symptoms and quality of life.\n\nAim of this registry trial is to evaluate the feasibility and efficacy of laparoscopic gastric pacemaker implantation for electrical stimulation (Enterra® system). Primary endpoints of the study are symptom severity, health-related quality of life, and frequency of hospitalization before and after pacemaker implantation, perioperative complication rate, and cost effectiveness.\n\nIt is hypothesized that implantation of the Enterra systems leads to a significant improvement of symptoms as well as an increase in health-related quality of life in patients with gastroparesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study includes patients with (1) scintigraphically proven gastroparesis, (2) failed conservative therapy, (3) who undergo laparoscopic gastric pacemaker implantation.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scintigraphically proven gastroparesis\n* Failed conservative therapy\n* Severe impairment of quality of life\n* Written informed consent\n* German language\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Prior gastric resection'}, 'identificationModule': {'nctId': 'NCT06661668', 'briefTitle': 'Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis', 'organization': {'class': 'OTHER', 'fullName': 'Evangelic Hospital Kalk Cologne'}, 'officialTitle': 'Laparoscopic Implantation of a Gastric Pacemaker is a Low-complication Alternative for Gastroparesis', 'orgStudyIdInfo': {'id': 'Gastroparesis_Enterra'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gastroparesis group', 'description': 'Patients scintigraphically proven gastroparesis and failed conservative therapy who undergo laparoscopic gastric pacemaker implantation', 'interventionNames': ['Device: Gastric pacemaker (Enterra system) implantation']}], 'interventions': [{'name': 'Gastric pacemaker (Enterra system) implantation', 'type': 'DEVICE', 'description': 'Laparascopic implantation of a gastric pacemaker (Enterra system) for patients with therapy refractive gastroparesis', 'armGroupLabels': ['Gastroparesis group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51103', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jessica M Leers, Prof.', 'role': 'CONTACT', 'email': 'jessica.leers@uk-koeln.de', 'phone': '0221-82892800'}], 'facility': 'Department of Functional Upper GI Surgery', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'centralContacts': [{'name': 'Jessica M Leers, Prof.', 'role': 'CONTACT', 'email': 'jessica.leers@uk-koeln.de', 'phone': '+49 221', 'phoneExt': '82892800'}], 'overallOfficials': [{'name': 'Jessica M Leers, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Functional Upper GI Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evangelic Hospital Kalk Cologne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Enterra Medical, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Jessica Leers', 'investigatorFullName': 'Jessica Leers', 'investigatorAffiliation': 'University of Cologne'}}}}