Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 10:51 PM
Study NCT ID:
NCT01078194
Status:
UNKNOWN
Last Update Posted:
2010-05-25
First Post:
2010-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Secondary Bypass Banding for Weight Regain or Weight Loss Failure After Lap. Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-24', 'studyFirstSubmitDate': '2010-03-01', 'studyFirstSubmitQcDate': '2010-03-01', 'lastUpdatePostDateStruct': {'date': '2010-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': '2 years', 'description': 'Excessive weight loss'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Weight regain', 'Weight loss failure', 'Gastric bypass'], 'conditions': ['Morbid Obesity']}, 'descriptionModule': {'briefSummary': 'This is an observational study on the efficacy of the secondary placement of the A.M.I Soft Gastric Band in weight regain or weight loss failure after lap. gastric bypass.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Weight regain of more than 10 kg from nadir or weight loss failure defined as excessive weight loss of less than 50% 18 months after laparoscopic gastric bypass', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight regain of more than 10 kg from nadir\n* Excessive weight loss of less than 50% at 18 months after laparoscopic gastric bypass\n\nExclusion Criteria:\n\n* Formerly leak at the gastrojejunostomy\n* Formerly open abdominal surgery\n* Anastomotic ulcer'}, 'identificationModule': {'nctId': 'NCT01078194', 'briefTitle': 'Secondary Bypass Banding for Weight Regain or Weight Loss Failure After Lap. Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Observational Study on the Secondary Placement of the A.M.I. Soft Gastric Band in Weight Regain or Weight Loss Failure After Lap. Gastric Bypass', 'orgStudyIdInfo': {'id': 'MUW ADIP STUDY 16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Weight regain / weight loss failure', 'description': 'Weight regain of more than 10 kg from or weight loss of less than 50% EWL 18 months after lap. gastric bypass', 'interventionNames': ['Device: Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)']}], 'interventions': [{'name': 'Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)', 'type': 'DEVICE', 'otherNames': ['A.M.I. Soft Gastric Band'], 'description': 'Secondary Placement of the A.M.I. Soft Gastric Band for laparoscopic bypass banding', 'armGroupLabels': ['Weight regain / weight loss failure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Gerhard Prager, M-D-', 'role': 'CONTACT', 'email': 'gerhard.prager@meduniwien.ac.at', 'phone': '+43-1-40400', 'phoneExt': '5621'}, {'name': 'Felix B Langer, M.D.', 'role': 'CONTACT', 'email': 'felix.langer@meduniwien.ac.at', 'phone': '+43-1-40400', 'phoneExt': '5621'}], 'facility': 'Medical University of Vienna, Department of Surgery', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Gerhard Prager, M.D.', 'role': 'CONTACT', 'email': 'gerhard.prager@meduniwien.ac.at', 'phone': '+43-1-40400', 'phoneExt': '5621'}, {'name': 'Felix B Langer, M.D.', 'role': 'CONTACT', 'email': 'felix.langer@meduniwien.ac.at', 'phone': '+43-1-40400', 'phoneExt': '5621'}], 'overallOfficials': [{'name': 'Gerhard Prager, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna, Department of Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Gerhard Prager / M.D.', 'oldOrganization': 'Medical University of Vienna / Department of Surgery'}}}}