Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-02-08 @ 7:29 PM
Study NCT ID:
NCT02731859
Status:
UNKNOWN
Last Update Posted:
2017-06-23
First Post:
2016-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EndoBarrier Register Deutschland-Safety and Efficacy of the Endoscopic Duodenal-Jejunal Bypass Sleeve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-22', 'studyFirstSubmitDate': '2016-01-27', 'studyFirstSubmitQcDate': '2016-04-02', 'lastUpdatePostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of HbA1C', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of Antidiabetic Medication', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Excess weight loss', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of BMI', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Weight reduction', 'timeFrame': 'From Implantation to at least 2 years follow up'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events', 'timeFrame': 'From Implantation to at least 2 years follow up', 'description': 'Adverse events associated to implantation, explantation or insertion of EndoBarrier such as bleeding, liver abscess, abdominal pain, nausea, vomiting, duodenal ulcers, duodenal perforation'}, {'measure': 'Improvement of subjective Arthropathia', 'timeFrame': 'From Implantation to at least 2 years follow up', 'description': 'Qualitative Measurement of improvement of subjective Arthropathia, no scale is used'}, {'measure': 'Smoking Status', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Time of implantation and explantation', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of fasting glucose', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of fasting insulin', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of fasting C-Peptide', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of systolic blood pressure', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of diastolic blood pressure', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of antihypertensive medication', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of total cholesterol', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of LDL-cholesterol', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Increase of HDL-cholesterol', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of fasting triglycerides', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of antihyperlipidemic medication', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of 25OHD3', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of Calcium', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of Ferritin', 'timeFrame': 'From Implantation to at least 2 years follow up', 'description': 'Ferritin will be measured'}, {'measure': 'Reduction of Hemoglobin', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of Vitamin B12', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of Albumin', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of Folic acid', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of Vitamin B1', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of Vitamin B6', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of CK', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of AST', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of ALT', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of hsCRP', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Duration of implantation process of the EndoBarrier in minutes', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Duration of ithe explantation process of the EndoBarrier in minutes', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of waist circumference', 'timeFrame': 'From Implantation to at least 2 years follow up'}, {'measure': 'Reduction of daily caloric intake', 'timeFrame': 'From Implantation to at least 2 years follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity', 'Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '29504053', 'type': 'DERIVED', 'citation': 'Riedel N, Laubner K, Lautenbach A, Schon G, Schlensak M, Stengel R, Eberl T, Dederichs F, Aberle J, Seufert J. Trends in BMI, Glycemic Control and Obesity-Associated Comorbidities After Explantation of the Duodenal-Jejunal Bypass Liner (DJBL). Obes Surg. 2018 Aug;28(8):2187-2196. doi: 10.1007/s11695-018-3144-9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study ist to determine long-term safety and efficacy in weight reduction and improvement of diabetes mellitus of the temporary, endoscopic duodenal-jejunal bypass-sleeve EndoBarrier® in a national registry.', 'detailedDescription': 'Long-term data are collected by approximately 30 German centers. An electronic Case-Report-Form (eCRF) was designed to collect relevant pre-specified items by the Clinical Trial Center North (CTC). All German sites that have implanted EndoBarrier® since 2010 were invited to provide patient results. Data-acquisition is projected to a period of 5 years and a maximum of 1000 patients. An extension of data-acquisition is planned.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with either Obesity and/or Diabetes mellitus who are treated with the EndoBarrier', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical decision for treatment with EndoBarrier\n* informed consent for registry participation\n\nExclusion Criteria:\n\n* Patients not meeting the inclusion criteria\n* age \\< 18'}, 'identificationModule': {'nctId': 'NCT02731859', 'acronym': 'EBRD', 'briefTitle': 'EndoBarrier Register Deutschland-Safety and Efficacy of the Endoscopic Duodenal-Jejunal Bypass Sleeve', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'EndoBarrier Register Deutschland', 'orgStudyIdInfo': {'id': 'EBRD 001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EndoBarrier', 'description': 'All patients with EndoBarrier treatment', 'interventionNames': ['Device: Insertion of EndoBarrier for approximately one year']}], 'interventions': [{'name': 'Insertion of EndoBarrier for approximately one year', 'type': 'DEVICE', 'description': 'Insertion of EndoBarrier for approximately one year then explantation and follow-up', 'armGroupLabels': ['EndoBarrier']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Augsburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Heinle', 'role': 'CONTACT'}], 'facility': 'Klinikum Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Loeff', 'role': 'CONTACT'}], 'facility': 'Evangelisches Krankenhaus Köln-Weyertal', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Donauwörth', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Eberl', 'role': 'CONTACT'}], 'facility': 'Donau-Ries Klinik Donauwörth', 'geoPoint': {'lat': 48.71804, 'lon': 10.7793}}, {'zip': '40215', 'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Gijbels', 'role': 'CONTACT'}], 'facility': 'St. Martinus Krankenhaus Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Forchheim', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dewald', 'role': 'CONTACT'}], 'facility': 'Klinikum Forchheim', 'geoPoint': {'lat': 49.71754, 'lon': 11.05877}}, {'city': 'Freiburg im Breisgau', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dr. Laubner/Prof. Seufert', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Freiburg- Abt. Innere Medizin II', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Gelsenkirchen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dederichs', 'role': 'CONTACT'}], 'facility': 'Marienhospital Gelsenkirchen', 'geoPoint': {'lat': 51.50508, 'lon': 7.09654}}, {'city': 'Göttingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Raddatz', 'role': 'CONTACT'}], 'facility': 'Universitätsmedizin Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Niesky', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stengel', 'role': 'CONTACT'}], 'facility': 'Krankenhaus Emmaus-Niesky', 'geoPoint': {'lat': 51.29241, 'lon': 14.82107}}, {'city': 'Schmalkalden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jung', 'role': 'CONTACT'}], 'facility': 'Elisabeth Klinikum Schmalkalde', 'geoPoint': {'lat': 50.72136, 'lon': 10.44386}}, {'city': 'Wuppertal', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Göbel', 'role': 'CONTACT'}], 'facility': 'Petrus Krankenhaus Wuppertal', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}], 'centralContacts': [{'name': 'Julia Hinz', 'role': 'CONTACT', 'email': 'ni.sauer@uke.de', 'phone': '040/741020901'}, {'name': 'Nina Sauer', 'role': 'CONTACT', 'email': 'ninasauer@ymail.com', 'phone': '01781642802'}], 'overallOfficials': [{'name': 'Jens Aberle', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital Hamburg, Endokrinology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'Morphic Medical Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}