Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-29 @ 5:50 PM
Study NCT ID:
NCT00999661
Status:
COMPLETED
Last Update Posted:
2014-02-07
First Post:
2009-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mschwier@its.jnj.com', 'phone': '513-337-1172', 'title': 'Michael Schwiers, Principal Biostatistician', 'organization': 'Ethicon Endo-Surgery, Inc.'}, 'certainAgreement': {'otherDetails': 'The PIs agreed that the first publication of results should be made in conjunction with the presentation of a joint, multicenter publication of the results with the PIs from all sites contributing data, analyses, and comments. If this publication was not submitted within 12 months after conclusion of the Study at all sites, or after Sponsor confirmed there would be no multicenter Study publication, whichever is first, the PIs could have published the results from their individual sites.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Realize Adjustable Gastric Band-C', 'description': 'All subjects implanted with the Realize Gastric Band-C.', 'otherNumAtRisk': 231, 'otherNumAffected': 200, 'seriousNumAtRisk': 231, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numAffected': 99}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numAffected': 71}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDAR'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numAffected': 48}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numAffected': 33}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDA'}], 'seriousEvents': [{'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA\\'}, {'term': 'Device migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Medical device complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Post procedural pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Excess Weight Change From Baseline to 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Realize Adjustable Gastric Band-C', 'description': 'All subjects implanted with the Realize Gastric Band-C.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.8', 'spread': '25.12', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '39.8', 'ciLowerLimit': '36.6', 'ciUpperLimit': '43.1', 'pValueComment': 'One-sample t-test for change from baseline', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '25.12', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 months', 'description': 'Percent excess weight change from baseline to 24 months was calculated as (the baseline weight minus the weight at 24 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.', 'unitOfMeasure': 'percent of excess weight at baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population - All subjects implanted with gastric band and signing informed consent.'}, {'type': 'SECONDARY', 'title': '% Excess Weight Change From Baseline to 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Realize Adjustable Gastric Band-C', 'description': 'All subjects implanted with the Realize Gastric Band-C.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.6', 'spread': '19.79', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '36.6', 'ciLowerLimit': '34.0', 'ciUpperLimit': '39.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '19.79', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Percent excess weight change from baseline to 12 months was calculated as (the baseline weight minus the weight at 12 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.', 'unitOfMeasure': 'percent of excess weight at baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'SECONDARY', 'title': 'Change in Body Mass Index From Baseline to 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Realize Adjustable Gastric Band-C', 'description': 'All subjects implanted with the Realize Gastric Band-C.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.97', 'spread': '5.233', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-7.97', 'ciLowerLimit': '-8.65', 'ciUpperLimit': '-7.29', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.233', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 months', 'description': 'Change in Body Mass Index from Baseline to 24 months with last observation carried forward. The calculation was performed as the Body Mass Index at 24 months minus the Body Mass Index at Baseline.', 'unitOfMeasure': 'kilograms per meters squared', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Realize Adjustable Gastric Band-C', 'description': 'All subjects implanted with the Realize Gastric Band-C.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Not meeting eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Subject recruitment began in November, 2009 at 7 surgical centers in the United States.', 'preAssignmentDetails': 'This was a longitudinal, single arm, observational, non-comparative study of clinical outcomes. Subjects were asked to consent to data collection to the study parameters from their study records.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Realize Adjustable Gastric Band-C', 'description': 'All subjects implanted with the Realize Gastric Band-C.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '214', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.4', 'spread': '12.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '180', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '231', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intent-to-Treat population defined as all subjects implanted with the Realize Gastric Band-C who signed informed consent.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 231}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-08', 'studyFirstSubmitDate': '2009-10-20', 'resultsFirstSubmitDate': '2013-08-14', 'studyFirstSubmitQcDate': '2009-10-20', 'lastUpdatePostDateStruct': {'date': '2014-02-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-08', 'studyFirstPostDateStruct': {'date': '2009-10-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Excess Weight Change From Baseline to 24 Months', 'timeFrame': 'Baseline to 24 months', 'description': 'Percent excess weight change from baseline to 24 months was calculated as (the baseline weight minus the weight at 24 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.'}], 'secondaryOutcomes': [{'measure': '% Excess Weight Change From Baseline to 12 Months', 'timeFrame': 'Baseline to 12 months', 'description': 'Percent excess weight change from baseline to 12 months was calculated as (the baseline weight minus the weight at 12 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.'}, {'measure': 'Change in Body Mass Index From Baseline to 24 Months', 'timeFrame': 'Baseline to 24 months', 'description': 'Change in Body Mass Index from Baseline to 24 months with last observation carried forward. The calculation was performed as the Body Mass Index at 24 months minus the Body Mass Index at Baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '23642493', 'type': 'RESULT', 'citation': 'Cunneen SA, Brathwaite CE, Joyce C, Gersin K, Kim K, Schram JL, Wilson EB, Schwiers M, Gutierrez M. Clinical outcomes of the Realize Adjustable Gastric Band-C at 2 years in a United States population. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):885-93. doi: 10.1016/j.soard.2013.02.009. Epub 2013 Mar 14.'}, {'pmid': '21775219', 'type': 'RESULT', 'citation': 'Cunneen SA, Brathwaite CE, Joyce C, Gersin K, Kim K, Schram JL, Wilson EB, Rodriguez CE, Gutierrez M. Clinical outcomes of the REALIZE adjustable gastric band-C at one year in a U.S. population. Surg Obes Relat Dis. 2012 May-Jun;8(3):288-95. doi: 10.1016/j.soard.2011.05.004. Epub 2011 May 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the results patients are obtaining with the Realize™ Adjustable Gastric Band-C during the first 24 months after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'At each participating center (after the initial 10 cases), all consecutively implanted patients, will be considered for the study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Received an implant with the Realize Band-C according to the following indications for use:\n\n 1. Body Mass Index (BMI) of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more co-morbid conditions.\n 2. Male and female adult patients (adult is defined as 18 years of age or older)\n 3. Failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs.\n2. Able to comprehend, follow, and give signed informed consent.\n\nExclusion Criteria:\n\n1. Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration or duodenal ulceration, or specific inflammation such as Crohn's disease;\n2. Severe cardiopulmonary disease or other serious organic disease;\n3. Upper gastrointestinal bleeding conditions such as esophageal or gastric varices or intestinal telangiectases;\n4. Portal hypertension;\n5. Anomalies of the gastrointestinal tract such as atresia or stenosis;\n6. Cirrhosis of the liver;\n7. Chronic pancreatitis;\n8. Localized or systemic infection;\n9. On chronic, long-term systemic steroid treatment or systemic steroids within 15 days of surgery;\n10. Unable or unwilling to comply with dietary restrictions required by this procedure;\n11. Known allergy to materials contained in the gastric band or its Injection Port;\n12. Women who are pregnant;\n13. Women at childbearing potential planning to get pregnant within 2 years or not using acceptable methods of contraception."}, 'identificationModule': {'nctId': 'NCT00999661', 'briefTitle': 'A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ethicon Endo-Surgery'}, 'officialTitle': 'A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C at 2 Years in a US Patient Population of Morbidly Obese Patients', 'orgStudyIdInfo': {'id': 'CI-09-0007'}}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Celebration', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.32529, 'lon': -81.53313}}, {'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'city': 'Holland', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.78752, 'lon': -86.10893}}, {'city': 'Patchogue', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.76565, 'lon': -73.01511}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ethicon Endo-Surgery', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}