protocolSection identificationModule nctId: NCT06338709, orgStudyIdInfo id: 11-002, briefTitle: Clinical Study Protocol for the Assessment of Safety and Efficacy of the BARICLIP®, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Advanced Bariatric Technology, class: INDUSTRY, collaborators name: NAMSA, descriptionModule briefSummary: Overweight and obesity are at epidemic proportions in the world population as well as in the United States, where nearly 42% of the adult population(1) is considered to meet the definition of obesity, namely a body mass index ("BMI") ≥ 30 kg/m2. Well-established links between obesity and increased morbidities and mortality make treatment of the utmost importance; however, there continues to be a significant unmet need for more effective treatments for obesity. Bariatric surgery is recognized as an effective treatment for obese patients, particularly in more severe cases where surgical restriction of the stomach's capacity and outlet size are considered necessary. The BariClip® is a laparoscopically implanted device for treatment of obesity and serves as an alternative to current existing technology for use in bariatric surgery. The BariClip® is a medical device, non-adjustable, resembling a clip that is placed parallel to the greater curvature of the stomach, causing restriction of the gastric lumen in a vertical fashion. This multi-center, randomized, moderate-lifestyle (program of diet and exercise) controlled pivotal study of the BariClip® device is intended to gather data to objectively support its safety and effectiveness for the treatment of obesity in adults and to ultimately support marketing authorization of this device as a viable alternative to existing bariatric surgical procedures. Specifically, this study aims to look at efficacy of the BariClip® device with regards to weight loss metrics and secondary health metrics and safety of the BariClip® device with regards to serious adverse events., conditionsModule conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 165, type: ESTIMATED, armsInterventionsModule interventions name: BariClip® Device Treatment, outcomesModule primaryOutcomes measure: Achieving ≥ 5% total body weight loss (TBWL) in 50% of treated subjects, primaryOutcomes measure: Achieving ≥ 5% superiority margin for weight loss in the treated group as compared to the control group, secondaryOutcomes measure: Weight and Height will be combined to report BMI in kg/m^2, secondaryOutcomes measure: Blood Pressure (BP) in mmHg, both systolic and diastolic, secondaryOutcomes measure: Diagnosis and/or Change in Severity of Diabetes Mellitus (DM), secondaryOutcomes measure: Weight in kilograms, secondaryOutcomes measure: Height in meters, secondaryOutcomes measure: Waist Circumference in centimeters, otherOutcomes measure: Incidence of Serious Adverse Events (SAEs), eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False