Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-02-22 @ 3:33 AM
Study NCT ID:
NCT00580502
Status:
COMPLETED
Last Update Posted:
2015-03-23
First Post:
2007-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'younh01@nyumc.org', 'phone': '2122632174', 'title': 'Heekoung Youn', 'organization': 'NYULMC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Entire 5 years study period', 'eventGroups': [{'id': 'EG000', 'title': 'LAP-BAND® Adjustable Gastric Band (LAGB®) Operations', 'description': 'A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities', 'otherNumAtRisk': 50, 'otherNumAffected': 4, 'seriousNumAtRisk': 50, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Port revision/replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Band revision/replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LAGB', 'description': 'LAGB surgery for the patient whose BMI between 30 and 40 kg/m\\^2'}], 'classes': [{'categories': [{'measurements': [{'value': '51.74', 'spread': '27.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.', 'unitOfMeasure': 'percentage of excess weight loss', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who underwent LAGB are included in the analysis population.'}, {'type': 'SECONDARY', 'title': 'Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LAGB', 'description': 'LAGB surgery for the patient whose BMI between 30 and 40 kg/m\\^2'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'spread': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'Change in level of LDL from baseline at 5 years', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who underwent LAGB are included in the analysis population.'}, {'type': 'SECONDARY', 'title': 'Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LAGB', 'description': 'LAGB surgery for the patient whose BMI between 30 and 40 kg/m\\^2'}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'spread': '58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'Change in level of Triglycerides from baseline at 5 years', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who underwent LAGB and had 5 year follow up visit are included in the analysis population.'}, {'type': 'SECONDARY', 'title': 'Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LAGB', 'description': 'LAGB surgery for the patient whose BMI between 30 and 40 kg/m\\^2'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'Change in level of HbA1c from baseline at 5 years', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who underwent LAGB and had 5 year f/u visit are included in the analysis population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lap-Band', 'description': 'Low BMI patients who will go through Lap-band surgery.\n\nLAP-BAND® Adjustable Gastric Band (LAGB®): Bariatric surgery: LAGB'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'LAP-BAND® Adjustable Gastric Band (LAGB®) Operations', 'description': 'A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '35.1', 'spread': '2.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-16', 'studyFirstSubmitDate': '2007-12-21', 'resultsFirstSubmitDate': '2014-12-29', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-16', 'studyFirstPostDateStruct': {'date': '2007-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery', 'timeFrame': '5 years', 'description': 'Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.'}], 'secondaryOutcomes': [{'measure': 'Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery', 'timeFrame': '5 years', 'description': 'Change in level of LDL from baseline at 5 years'}, {'measure': 'Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery', 'timeFrame': '5 years', 'description': 'Change in level of Triglycerides from baseline at 5 years'}, {'measure': 'Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery', 'timeFrame': '5 years', 'description': 'Change in level of HbA1c from baseline at 5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity, 50 lbs overweight'], 'conditions': ['Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://nyuweightloss.org', 'label': 'NYU Program for Surgical Weight Loss'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the safety and efficacy of Gastric Banding for patients with body mass index (BMI) between 30-40 kg/m2 with medical conditions related to obesity.', 'detailedDescription': "TITLE OF STUDY:A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities\n\nCLINICAL PHASE: Phase III new indication for use of the device not yet approved by FDA\n\nSTUDY OBJECTIVES\n\n* To determine the safety and efficacy of the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities\n* To determine long-term effects on patients' co-morbidities\n\nSTUDY VARIABLES: Morbidity \\& mortality, percent of excess weight loss, nutritional status, improvement of pre-operative co-morbidities, weight loss maintained, and quality of life evaluation\n\nDESIGN: Prospective single center study"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be at least 18 and equal to or less than 60 years of age.\n* BMI of at least 30 and maximum BMI of 40 with co-morbidities\n* Willingness to comply with dietary restrictions required by the protocol\n* History of obesity for at least 5 years\n* History of at least 6 months of documented failures with traditional non-surgical weight loss methods\n* Willingness to follow protocol requirements\n* If female with childbearing potential, using an appropriate form of contraception\n\nExclusion Criteria:\n\n* Age less than 18, age greater than 60\n* Pregnancy\n* History of major depressive disorder or psychosis\n* Previous bariatric surgery or previous gastric surgery\n* Presence of achalasia\n* Presence of portal hypertension, cirrhosis, and/or varices\n* Patient with inflammatory disease of the gastrointestinal tract such as Crohn's Disease\n* Patients with autoimmune connective tissue disorders\n* Patients with acute abdominal infections\n* Any condition that, in the judgment of the investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study"}, 'identificationModule': {'nctId': 'NCT00580502', 'acronym': 'LBMI', 'briefTitle': 'Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'A Prospective Study to Evaluate the Safety and Efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) Operations for Patients With BMI Between 30-40 kg/m2 With Co-morbidities', 'orgStudyIdInfo': {'id': 'H # 10686'}, 'secondaryIdInfos': [{'id': '10686', 'type': 'OTHER', 'domain': 'NYULMC IRB'}, {'id': 'G030190', 'type': 'OTHER', 'domain': 'FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LAGB for low BMI patients', 'description': 'the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities', 'interventionNames': ['Device: LAP-BAND® Adjustable Gastric Band (LAGB®)']}], 'interventions': [{'name': 'LAP-BAND® Adjustable Gastric Band (LAGB®)', 'type': 'DEVICE', 'description': 'Bariatric surgery for patient whose BMI is between 30 and 40 kg/m\\^2', 'armGroupLabels': ['LAGB for low BMI patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christine Ren-Fielding, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYUSOM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research coordinator', 'investigatorFullName': 'Heekoung A Youn', 'investigatorAffiliation': 'NYU Langone Health'}}}}