Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT01015469
Status:
UNKNOWN
Last Update Posted:
2011-02-17
First Post:
2009-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 384}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-16', 'studyFirstSubmitDate': '2009-11-17', 'studyFirstSubmitQcDate': '2009-11-17', 'lastUpdatePostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative reduction of body mass index (BMI) and maintenance related to used bariatric procedure', 'timeFrame': '0, 3, 6, 12 months and 2, 3, 4, 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bariatric', 'surgery', 'obesity', 'Roux-en-Y', 'gastric', 'medical device', 'bypass', 'adiposity', 'GaBP-Ring', 'BMI', 'banded', 'laparoscopic'], 'conditions': ['Morbid Obesity Requiring Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'Banded Versus Conventional Laparoscopic Roux-en-Y Gastric Bypass (GABY).\n\nThe aim of this novel study is to evaluate, if an additional restrictive silastic ring can avoid dilation of the gastro-entero anastomosis and adjacent small bowel with consecutive better postoperative weight loss and significantly improved long-term weight maintenance.\n\nThe study will not investigate the GaBP-Ring as medical product but the effect of the GaBP-Ring on weight loss in comparison to gastric bypass alone.', 'detailedDescription': 'GABY is designed as an international, multi center, open, prospective, randomized study to compare two methods of bariatric surgery: Banded versus conventional laparoscopic Roux-en-Y gastric bypass.\n\nAt least 16 international high volume centres of excellence in bariatric surgery and at least 384 patients (24 patients at each center) in total will be included into this study. At least 320 patients must have completed the study after 5 years.\n\nSurgery will be performed according to standardized operating protocol. The group A (control group) will follow the worldwide golden standard of bariatric surgery (gastric bypass). Patients randomised to group B will receive in addition a restrictive silastic ring. The ring is a launched medical product and is registered in the European Community.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI ≥ 40 kg /m2 to ≤ 50 kg/m2\n* Eating habit: sweet eater and volume eater\n* Signed informed consent\n* Patients with one or more of the following comorbidities: Hypertension, Diabetes mellitus Type 2, Hyperlipidemia, Hyperuricemia, Sleep apnea, Degenerative diseases of: Spine osteochondrosis, hip, knee, feet\n\nExclusion Criteria:\n\n* History of obesity surgery\n* History of major abdominal surgery with consecutive malabsorption (no resections of the stomach, small and large bowel (exception: appendectomy)\n* Patients not eligible to implement silastic ring size 6.5 cm\n* History of drug or alcohol abuse\n* History of major psychiatric illness conflicting with patient's compliance\n* History of recent or chronic steroid medication\n* Autoimmune disease\n* Inflammatory bowel disease or malabsorptive disease\n* Liver cirrhosis (CHILD B + C)\n* Active viral or bacterial disease (e.g. HIV, Hepatitis B or C, Tbc etc.)\n* Pregnant women or women with childbearing potential without efficient contraception\n* History of cancer in the last five years\n* Need of long-term anticoagulant medication for any reason\n* Any medication with ingredient ASA"}, 'identificationModule': {'nctId': 'NCT01015469', 'acronym': 'GABY', 'briefTitle': 'Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)', 'organization': {'class': 'OTHER', 'fullName': 'ClinTrio Ltd.'}, 'officialTitle': 'International, Multi Centre, Open, Prospective, Randomized Study: Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)', 'orgStudyIdInfo': {'id': 'IT5448081'}, 'secondaryIdInfos': [{'id': 'EudraCT-No. 2009-016718-26'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Conventional laparoscopic Roux-en-Y gastric bypass (Golden Standard)', 'interventionNames': ['Procedure: Conventional laparoscopic Roux-en-Y gastric bypass']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring', 'interventionNames': ['Procedure: conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring']}], 'interventions': [{'name': 'Conventional laparoscopic Roux-en-Y gastric bypass', 'type': 'PROCEDURE', 'description': 'Conventional laparoscopic Roux-en-Y gastric bypass', 'armGroupLabels': ['Group A']}, {'name': 'conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring', 'type': 'PROCEDURE', 'description': 'conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring (GaBP-Ring)', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5400', 'city': 'Hallein', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Austria', 'facility': 'Hospital Hallein (Scientific Review Board)', 'geoPoint': {'lat': 47.68333, 'lon': 13.1}}, {'zip': '8000', 'city': 'Bruges', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Bruno Dillemans, MD', 'role': 'CONTACT'}], 'facility': 'Hospital AZ St.-Jan AV', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '9200', 'city': 'Dendermonde', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Jaques Himpens, MD', 'role': 'CONTACT'}], 'facility': 'AZ Sint-Blasius', 'geoPoint': {'lat': 51.02869, 'lon': 4.10106}}, {'zip': '9100', 'city': 'Sint-Niklaas', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Luc Lemmens, MD', 'role': 'CONTACT'}], 'facility': 'AZ Nikolaas', 'geoPoint': {'lat': 51.16509, 'lon': 4.1437}}, {'zip': '14059', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Volker Lange, Prof.', 'role': 'CONTACT'}], 'facility': 'Privatpraxis Chirurgie bei Schlossparkklinik', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Konrad W Karcz, MD', 'role': 'CONTACT'}], 'facility': 'Albert-Ludwigs-University', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Oliver Mann, MD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Hamburg-Eppendorf (UKE)', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '81679', 'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Günther Meyer, MD', 'role': 'CONTACT'}], 'facility': 'Chirurgische Klinik München-Bogenhausen GmbH', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '78011', 'city': 'Villingen-Schwenningen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Norbert Runkel, Prof.', 'role': 'CONTACT'}], 'facility': 'Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH', 'geoPoint': {'lat': 48.06226, 'lon': 8.49358}}, {'zip': '6401', 'city': 'Heerlen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jan W.M. Greve, MD', 'role': 'CONTACT'}], 'facility': 'Atruim Medical Centre', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'zip': '90-152', 'city': 'Lodz', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Tomasz Szewczyk, MD', 'role': 'CONTACT'}], 'facility': 'Medical University of Lodz', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '1150-199', 'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Rui Ribeiro, MD', 'role': 'CONTACT'}], 'facility': 'Centro Hospitalar de Lisboa Central', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4520-211', 'city': 'Santa Maria de Feira', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Mario Nora, MD', 'role': 'CONTACT'}], 'facility': 'Hospital de Sao Sebastiano'}, {'zip': '2172', 'city': 'Jeddah', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Walid Bukhari, MD', 'role': 'CONTACT'}], 'facility': 'International Medical Center', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}], 'centralContacts': [{'name': 'Burkhart Frankenberger', 'role': 'CONTACT', 'email': 'info@clintrio.com', 'phone': '+49-511-38814-0'}, {'name': 'Maria Noraman', 'role': 'CONTACT', 'email': 'm.noraman@clintrio.com', 'phone': '+49-511-38814-0'}], 'overallOfficials': [{'name': 'Konrad W Karcz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert-Ludwigs-University of Freiburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ClinTrio Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Burkhart Frankenberger - Director-', 'oldOrganization': 'ClinTrio Ltd.'}}}}