Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT00394212
Status:
TERMINATED
Last Update Posted:
2016-09-21
First Post:
2006-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Dawn.Heimer@crbard.com', 'phone': '401-825-8681', 'title': 'Dawn Heimer, Clinical Research', 'organization': 'Davol Inc., Subsidiary of C.R. Bard'}, 'certainAgreement': {'otherDetails': 'First publication of study results will be the multicenter results. In the event no multicenter publication has been made within one to two years of the completion of the study at all centers, Investigators will be free to publish their own single-center results. Investigators seeking publication must submit a draft for sponsor review at least 60 days prior to submission of the draft for publication. Sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Limitations of this study are that study enrollment was prematurely discontinued; therefore the study was underpowered for the analysis of both the primary and secondary effectiveness endpoints.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'EndoCinch Suturing System:Transoral Suturing', 'description': 'Transoral suturing of the dilated gastrojejunostomy', 'otherNumAtRisk': 48, 'otherNumAffected': 18, 'seriousNumAtRisk': 48, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Sham Endoscopy', 'description': 'Sham Endoscopy (suturing not performed)', 'otherNumAtRisk': 29, 'otherNumAffected': 10, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Adhesion-related intestinal obstruction (from prior surgery)', 'notes': 'Adhesion from initial gastric bypass surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary edema secondary to fluid overload', 'notes': 'edema secondary to fluid overload following study procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Weight Loss (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EndoCinch Suturing System:Transoral Suturing', 'description': 'Transoral suturing of the dilated gastrojejunostomy'}, {'id': 'OG001', 'title': 'Sham Endoscopy', 'description': 'Sham Endoscopy (suturing not performed)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.066', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value from non-parametric Mann-Whitney-Wilcoxon test comparing treatments.', 'groupDescription': 'Based on a 2-group test of means for unequal variance and unequal sample size (2:1 randomization ratio) with alpha = 0.05 and a power of 80%, the sample size required was 132; 88 subjects in the Transoral Suturing arm and 44 in the Sham Endoscopy arm. The study was prematurely discontinued due to reasons unrelated to safety and effectiveness and therefore was underpowered for evaluation of the primary and secondary hypotheses.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Percent Weight Loss is computed as \\[(Baseline weight - 6 mo. weight) / Baseline weight\\] \\* 100', 'unitOfMeasure': 'percentage of weight lost', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT using Last Observation Carried Forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Subjects Achieving 15% Excess Weight Loss (EWL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EndoCinch Suturing System:Transoral Suturing', 'description': 'Transoral suturing of the dilated gastrojejunostomy'}, {'id': 'OG001', 'title': 'Sham Endoscopy', 'description': 'Sham Endoscopy (suturing not performed)'}], 'classes': [{'categories': [{'measurements': [{'value': '41.3', 'groupId': 'OG000'}, {'value': '25.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.317', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "P-value from two-sided Fisher's exact test comparing percents achieving 15% EWL at 6 months for the two treatments.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': '%Excess Weight Loss (%EWL) is computed as:\\[(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)\\]\\*100.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, Last Observation Carried Forward'}, {'type': 'SECONDARY', 'title': 'Subjects Achieving Weight Stabilization at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EndoCinch Suturing System:Transoral Suturing', 'description': 'Transoral suturing of the dilated gastrojejunostomy'}, {'id': 'OG001', 'title': 'Sham Endoscopy', 'description': 'Sham Endoscopy (suturing not performed)'}], 'classes': [{'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000'}, {'value': '77.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "P-value from two-sided Fisher's exact test comparing percents achieved for the two treatments.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Weight is stabilized if 6 month weight is +/- 2% from baseline weight.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, Last Observation Carried Forward'}, {'type': 'SECONDARY', 'title': 'Subjects Achieving 20% Excess Weight Loss at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EndoCinch Suturing System:Transoral Suturing', 'description': 'Transoral suturing of the dilated gastrojejunostomy'}, {'id': 'OG001', 'title': 'Sham Endoscopy', 'description': 'Sham Endoscopy (suturing not performed)'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '14.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.174', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "P-value from two-sided Fisher's exact test comparing percents achieved for the two treatments.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': '%Excess Weight Loss (%EWL) is computed as: \\[(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)\\]\\*100', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, Last Observation Carried Forward'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EndoCinch Suturing System:Transoral Suturing', 'description': 'Transoral suturing of the dilated gastrojejunostomy'}, {'id': 'FG001', 'title': 'Sham Endoscopy', 'description': 'Sham Endoscopy (suturing not performed)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '2 subjects assigned to suturing underwent sham procedure, results based on Intent-To-Treat (ITT)', 'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': '6 Week Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': '3 Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': '6 Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were recruited at bariatric centers of excellence with screening initiated on 25Oct2006. The first randomized procedure was performed on 3Apr2007. The last subject follow-up was performed 8May2009.', 'preAssignmentDetails': 'Prior to enrollment, prospective candidates having provided informed consent were screened for eligibility during a formal 6 week screening period. Screening performed by a multidisciplinary team including surgeon and/or endoscopist, psychiatric professional and registered dietician.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'EndoCinch Suturing System:Transoral Suturing', 'description': 'Transoral suturing of the dilated gastrojejunostomy'}, {'id': 'BG001', 'title': 'Sham Endoscopy', 'description': 'Sham Endoscopy (suturing not performed)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '47.6', 'spread': '7.0', 'groupId': 'BG001'}, {'value': '47.6', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'whyStopped': 'For business reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-12', 'studyFirstSubmitDate': '2006-10-27', 'resultsFirstSubmitDate': '2011-08-03', 'studyFirstSubmitQcDate': '2006-10-30', 'lastUpdatePostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-08', 'studyFirstPostDateStruct': {'date': '2006-10-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Loss (%)', 'timeFrame': '6 months', 'description': 'Percent Weight Loss is computed as \\[(Baseline weight - 6 mo. weight) / Baseline weight\\] \\* 100'}], 'secondaryOutcomes': [{'measure': 'Subjects Achieving 15% Excess Weight Loss (EWL)', 'timeFrame': '6 months', 'description': '%Excess Weight Loss (%EWL) is computed as:\\[(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)\\]\\*100.'}, {'measure': 'Subjects Achieving Weight Stabilization at 6 Months', 'timeFrame': '6 months', 'description': 'Weight is stabilized if 6 month weight is +/- 2% from baseline weight.'}, {'measure': 'Subjects Achieving 20% Excess Weight Loss at 6 Months', 'timeFrame': '6 months', 'description': '%Excess Weight Loss (%EWL) is computed as: \\[(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)\\]\\*100'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Weight Loss', 'Transoral Suturing', 'Dilated gastrojejunostomy', 'Inadequate weight loss following primary RYGB'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '23567348', 'type': 'DERIVED', 'citation': 'Thompson CC, Chand B, Chen YK, DeMarco DC, Miller L, Schweitzer M, Rothstein RI, Lautz DB, Slattery J, Ryan MB, Brethauer S, Schauer P, Mitchell MC, Starpoli A, Haber GB, Catalano MF, Edmundowicz S, Fagnant AM, Kaplan LM, Roslin MS. Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. Gastroenterology. 2013 Jul;145(1):129-137.e3. doi: 10.1053/j.gastro.2013.04.002. Epub 2013 Apr 5.'}]}, 'descriptionModule': {'briefSummary': 'It is estimated that up to 20% of patients who have Roux-en-Y Gastric Bypass (RYGB) surgery will not meet their weight loss goal, or may even regain some of the weight they initially lost. One possible explanation is that the opening between the stomach pouch and the intestine becomes stretched. If this opening becomes too wide, food may be able to pass from the stomach to the intestine too quickly - causing patients to feel less full after eating.\n\nFor some patients, doctors may recommend additional invasive surgery to tighten the opening between the stomach pouch and the small intestine. Although this may help patients resume their weight loss, the risk of complications during a second surgical procedure is significantly higher than the risk during the original gastric bypass.\n\nThe purpose of this study is to evaluate an incisionless procedure for patients who have either had inadequate weight loss or have regained weight following gastric bypass. The procedure is designed to tighten the opening between the stomach pouch and the small intestine, which may slow down the passage of food to help patients feel full longer after eating.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 6 months post primary RYGB with inadequate weight loss or weight regain\n* BMI \\>30 and ≤ 50\n* Dilated gastrojejunal anastomosis\n* Successfully completes screening process\n* Signed consent\n\nExclusion Criteria:\n\n* Recently quit smoking or plan to quit within the next year\n* Pregnant or planning to become pregnant over the course of the next 9 months\n* Mallampati score of 4\n* Serious systemic disease or active disease of the gastrointestinal tract\n* Gastric pouch abnormalities\n* Significant movement limitations\n* Use of weight-promoting or weight-reduction drugs during study period\n* Severe eating disorders\n* Uncontrolled depression or psychoses\n* Ongoing severe complication resulting from initial RYGB or other condition that in the investigators' assessment would make the patient an unsuitable candidate for the study procedure\n* History of significant cardiovascular, cerebrovascular or pulmonary disease\n* Not a candidate for conscious or general sedation\n* Anticoagulant therapies\n* Active substance abuse\n* Life expectancy \\< 1 year\n* Enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this trial's study endpoints"}, 'identificationModule': {'nctId': 'NCT00394212', 'briefTitle': 'Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction (RESTORe) for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass Surgery', 'orgStudyIdInfo': {'id': 'DVL-EC-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Transoral suturing of the dilated gastrojejunostomy', 'interventionNames': ['Device: Transoral Suturing']}, {'type': 'SHAM_COMPARATOR', 'label': '2', 'description': 'Sham Endoscopy (suturing not performed)', 'interventionNames': ['Other: Sham Endoscopy']}], 'interventions': [{'name': 'Transoral Suturing', 'type': 'DEVICE', 'description': 'suturing of anastomosis', 'armGroupLabels': ['1']}, {'name': 'Sham Endoscopy', 'type': 'OTHER', 'description': 'suturing not performed', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. R. Bard', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}