Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-01-15 @ 3:41 PM
Study NCT ID:
NCT06594718
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Treatment of Zenker's Diverticulum (ZENKTUN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016672', 'term': 'Zenker Diverticulum'}], 'ancestors': [{'id': 'D004936', 'term': 'Diverticulum, Esophageal'}, {'id': 'D004240', 'term': 'Diverticulum'}, {'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2028-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-10', 'studyFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Symptomatic recurrence rate after endoscopic tunnelization therapy (Z-POEM) compared to non-tunnelization techniques in patients with symptomatic Zenker's diverticulum.", 'timeFrame': '12 months', 'description': 'Symptomatic recurrence is defined by:\n\nClinical resolution after endoscopic treatment, as assessed clinically at 3 months, with an Augsburg score \\<5.\n\nReappearance of clinical symptoms, following clinical resolution after endoscopic treatment, with an Augsburg score ≥5.'}], 'secondaryOutcomes': [{'measure': 'Clinical success rate after endoscopic treatment.', 'timeFrame': '3 months', 'description': 'Clinical success is assessed using the Augsburg scale, with a score \\<5.'}, {'measure': 'Variation in Augsburg score at different time points', 'timeFrame': '3 months, 6 months, 12 months, and 24 months', 'description': 'comparing the Augsburg scores at each time point with baseline data for each patient.'}, {'measure': 'Complication rate associated with the endoscopic procedure', 'timeFrame': '15 days', 'description': 'Number of patients with at least one of the following complications: Pneumoperitoneum insufflation, Fever during hospitalization (T \\> 38.5°C), Post-procedure hemorrhage, Post-procedure antibiotic therapy, Post-procedure scan, Intensive care unit/rehabilitation hospitalization, or Surgery for complications'}, {'measure': 'Radiographic resolution rate of the diverticulum', 'timeFrame': '3 months', 'description': "Radiographic resolution rate of the diverticulum, assessed by a TOGD (barium swallow) at 3 months: Radiographic resolution is defined by a reduction in the diverticulum's volume between the preoperative TOGD and the TOGD at 3 months. The volume is estimated from the millimeter measurements of the diverticulum in its craniocaudal, anteroposterior, and laterolateral dimensions. The definitions are as follows:\n\nComplete resolution: Complete disappearance of the diverticulum. Partial resolution: Reduction in diverticular volume of at least 50%. Minor resolution: Reduction in diverticular volume between 20% and 50%. No resolution: Reduction in diverticular volume \\< 20%."}, {'measure': 'Symptomatic Recurrence Rate Post-Treatment:', 'timeFrame': 'at 3, 6, 12, and 24 Months', 'description': 'Number of patients with symptomatic recurrence, defined as the reappearance of clinical symptoms at 3, 6, 12, and 24 months after endoscopic treatment, with an Augsburg score of ≥5.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Zenker's diverticulum", 'Z-POEM', 'Diverticuloscope', 'Knife Septotomy', 'Clutch Cutter'], 'conditions': ['Zenker Diverticulum']}, 'descriptionModule': {'briefSummary': "Prospective comparative observational study in numerous reference centers in France, comparing Tunnelization (Z-POEM) versus Non-Tunnelization Techniques according to the usual practices. This is a prospective, comparative, observational, multicenter study with the primary objective of comparing the symptomatic recurrence rate one year after endoscopic tunnelization therapy (Z-POEM) versus non-tunnelization techniques in patients with symptomatic Zenker's diverticulum."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patient referred for endoscopic treatment of symptomatic Zenker's diverticulum", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with symptomatic Zenker's diverticulum (Augsburg score ≥5 )\n* Diagnostic evaluation including esophagogastroduodenoscopy (EGD) and a barium swallow (TOGD) with measurement of the diverticulum's height.\n* Patient aged 18 years or older\n* Patient with ASA 1, ASA 2, ASA 3 status\n* No participation in another concurrent clinical study\n\nExclusion Criteria:\n\n* Patient under 18 years old\n* Patient with ASA 4 or ASA 5 status\n* Pregnant woman\n* Patient with coagulation disorders preventing the performance a polypectomy: PT \\< 50%, Platelets \\< 50,000/mm³, ongoing effective anticoagulation, or current clopidogrel use.\n* Patient who has already undergone initial endoscopic or surgical treatment for Zenker's diverticulum"}, 'identificationModule': {'nctId': 'NCT06594718', 'briefTitle': "Endoscopic Treatment of Zenker's Diverticulum (ZENKTUN)", 'organization': {'class': 'OTHER', 'fullName': "Société Française d'Endoscopie Digestive"}, 'officialTitle': "Endoscopic Treatment of Zenker's Diverticulum: a Prospective Observational Study Comparing Tunnelization (Z-POEM) Versus Non-Tunnelization Techniques", 'orgStudyIdInfo': {'id': 'SFED 157'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endoscopic treatment with (Z-POEM)', 'description': 'Patients undergoing a peroral endoscopic myotomy using a tunneling method to access the target zone.', 'interventionNames': ['Procedure: Endoscopic diverticulotomy with Z-POEM']}, {'label': 'Endoscopic treatment using a non-tunnelization technique', 'description': 'Patients undergoing a peroral endoscopic myotomy using a no-tunneling method (Diverticuloscope, Knife Septotomy, and Clutch Cutter) to access the target zone.', 'interventionNames': ['Procedure: Endoscopic diverticulotomy using a non-tunnelization technique']}], 'interventions': [{'name': 'Endoscopic diverticulotomy with Z-POEM', 'type': 'PROCEDURE', 'description': 'Endoscopic diverticulotomy with Z-POEM', 'armGroupLabels': ['Endoscopic treatment with (Z-POEM)']}, {'name': 'Endoscopic diverticulotomy using a non-tunnelization technique', 'type': 'PROCEDURE', 'description': 'Endoscopic diverticulotomy with diverticuloscope, Knife Septotomy, or Clutch Cutter', 'armGroupLabels': ['Endoscopic treatment using a non-tunnelization technique']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bertrand BRIEAU, MD', 'role': 'CONTACT', 'email': 'bertrand.brieau@gmail.com', 'phone': '+33 650266383'}, {'name': 'Maira MORENO, PhD', 'role': 'CONTACT', 'email': 'rechercheclinique@sfed.org', 'phone': '+33 472117513'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Société Française d'Endoscopie Digestive", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor, Principal Investigator', 'investigatorFullName': 'Bertrand Brieau', 'investigatorAffiliation': "Société Française d'Endoscopie Digestive"}}}}