Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-03-05 @ 3:31 AM
Study NCT ID:
NCT01060592
Status:
COMPLETED
Last Update Posted:
2013-04-08
First Post:
2010-01-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LapBand Adjustment to Improve Early Weight Loss
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': 'jodea@crospon.com', 'phone': '+353-91-519880', 'title': "John O'Dea PhD", 'organization': 'Crospon'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Historic', 'description': 'Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stoma Adjustment at Surgery', 'description': 'The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery', 'otherNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '%Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Historic', 'description': 'Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records'}, {'id': 'OG001', 'title': 'Stoma Adjustment at Surgery', 'description': 'The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '15.63', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '20.8', 'spread': '10.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-6 weeks post surgery', 'unitOfMeasure': '%EWL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Band Adjustments Required in the First Year After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Historic', 'description': 'Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records'}, {'id': 'OG001', 'title': 'Stoma Adjustment at Surgery', 'description': 'The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '6.47', 'spread': '3.15', 'groupId': 'OG000'}, {'value': '6.66', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'unitOfMeasure': 'Number of Adjustments', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '%Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Historic', 'description': 'Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records'}, {'id': 'OG001', 'title': 'Stoma Adjustment at Surgery', 'description': 'The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '16.33', 'spread': '9.54', 'groupId': 'OG000'}, {'value': '23.07', 'spread': '11.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-6 weeks post surgery', 'unitOfMeasure': '%EWL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '% Excess Weight Loss 12 Months After Surgery (Large and Small Bands)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Historic', 'description': 'Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records'}, {'id': 'OG001', 'title': 'Stoma Adjustment at Surgery', 'description': 'The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'spread': '15', 'groupId': 'OG000'}, {'value': '50.4', 'spread': '24.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12m post surgery', 'unitOfMeasure': '%EWL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '% Excess Weight Loss 12 Months After Surgery (Small Bands Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Historic', 'description': 'Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records'}, {'id': 'OG001', 'title': 'Stoma Adjustment at Surgery', 'description': 'The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '48.71', 'spread': '15.61', 'groupId': 'OG000'}, {'value': '60.32', 'spread': '22.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12m post surgery', 'unitOfMeasure': '%EWL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stoma Adjustment at Surgery', 'description': 'The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery'}, {'id': 'FG001', 'title': 'Historic', 'description': 'Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records'}], 'periods': [{'title': '4-6w', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}, {'title': '12m', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'For some pts, %EWL were not taken/available in the 4-6w period but were available for the 12m period', 'groupId': 'FG000', 'numSubjects': '35'}, {'comment': 'For some pts, %EWL were not taken/available in the 4-6w period but were available for the 12m period', 'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'comment': 'Historic data was not available at 12m for 18 of the historic controls', 'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '18'}]}]}], 'recruitmentDetails': '35 pts recruited between Oct 2009 and Jan 2010', 'preAssignmentDetails': 'N/A - Single arm non-randomized study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Historic', 'description': 'Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records'}, {'id': 'BG001', 'title': 'Stoma Adjustment at Surgery', 'description': 'The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.0', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '40.1', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '42.8', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-04', 'studyFirstSubmitDate': '2010-01-30', 'resultsFirstSubmitDate': '2013-02-20', 'studyFirstSubmitQcDate': '2010-01-30', 'lastUpdatePostDateStruct': {'date': '2013-04-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-26', 'studyFirstPostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '%Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)', 'timeFrame': '4-6 weeks post surgery'}, {'measure': '%Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only)', 'timeFrame': '4-6 weeks post surgery'}, {'measure': '% Excess Weight Loss 12 Months After Surgery (Large and Small Bands)', 'timeFrame': '12m post surgery'}, {'measure': '% Excess Weight Loss 12 Months After Surgery (Small Bands Only)', 'timeFrame': '12m post surgery'}], 'secondaryOutcomes': [{'measure': 'Number of Band Adjustments Required in the First Year After Surgery', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastric Band', 'LapBand', 'Bariatric Surgery'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': "Snow RG, O'Dea J. Does Intraoperative Gastric Band Adjustment to a Targeted Stoma Size Improve Weight Loss? One-year Results of a Feasibility Trial Bariatric Times. 2012;9(1):10-12."}]}, 'descriptionModule': {'briefSummary': 'Subjects having a gastric band fitted will have the first band adjustment done at surgery. The stoma will be set to 7mm using the EndoFLIP system to measure stoma size. Thereafter, band adjustments will be made using an adjustment chart, created at surgery, which shows stoma size versus band fill, to make adjustments in the normal follow-up visits. It is hypothesized that an early adjustment at surgery will promote earlier weight loss, and result in fewer band adjustments being required in the first year after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing gastric band surgery\n* Over 18 years of age\n\nExclusion Criteria:\n\n* Actively bleeding varices'}, 'identificationModule': {'nctId': 'NCT01060592', 'briefTitle': 'LapBand Adjustment to Improve Early Weight Loss', 'organization': {'class': 'INDUSTRY', 'fullName': 'Crospon'}, 'officialTitle': 'Effect on Early Weight Loss by Adjusting Gastric Band During Surgery', 'orgStudyIdInfo': {'id': '2009-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stoma Adjustment at Surgery', 'description': 'The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery. EndoFLIP device (FDA Device Listing Number : D091203)will be used to make the adjustment.', 'interventionNames': ['Device: EndoFLIP device (FDA Device Listing Number : D091203)']}, {'type': 'NO_INTERVENTION', 'label': 'Historic', 'description': 'Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records. Band adjustments are made in a heuristic fashion during the year after surgery using the experience of surgeon alone'}], 'interventions': [{'name': 'EndoFLIP device (FDA Device Listing Number : D091203)', 'type': 'DEVICE', 'description': 'The EndoFLIP balloon catheter will be introduced to the band and used to permit the band stoma size to be adjusted to 7mm.', 'armGroupLabels': ['Stoma Adjustment at Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76054', 'city': 'Hurst', 'state': 'Texas', 'country': 'United States', 'facility': 'Specialty Surgery of Fort Worth', 'geoPoint': {'lat': 32.82346, 'lon': -97.17057}}], 'overallOfficials': [{'name': 'Robert G Snow, DO FACOS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AIGB'}, {'name': "John O'Dea, PhD", 'role': 'STUDY_DIRECTOR', 'affiliation': 'Crospon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Crospon', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}