Clinical Study Protocol for the Assessment of Safety and Efficacy of the BARICLIP®

Обзор

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.

Вмешательства

• Устройство BariClip® Device Treatment
  Device Administration (Implantation)

Первичные конечные точки

• Achieving ≥ 5% total body weight loss (TBWL) in 50% of treated subjects [Срок оценки: 12 months]
• Achieving ≥ 5% superiority margin for weight loss in the treated group as compared to the control group [Срок оценки: 12 months]

Вторичные конечные точки (6)

• Weight and Height will be combined to report BMI in kg/m^2 [Срок оценки: 12 months]
• Blood Pressure (BP) in mmHg, both systolic and diastolic [Срок оценки: 12 months]
• Diagnosis and/or Change in Severity of Diabetes Mellitus (DM) [Срок оценки: 12 months]
• Weight in kilograms [Срок оценки: 12 months]
• Height in meters [Срок оценки: 12 months]
• Waist Circumference in centimeters [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Age ≥22 years and ≤65 years
• Have signed an Informed Consent Form
• BMI 30-34.9 (with comorbidity) and 35-45 (with or without comorbidity) kg/m2
• Willing to comply with study requirements
• Subjects of childbearing potential not intending to become pregnant for the duration of their trial participation, with a documented negative pregnancy test and documentation of contraception confirmation and method
• History of obesity and being overweight (BMI >30kg/m2) for at least 1 year
• History of failure of non-surgical weight loss methods
• Fully ambulatory without any severe chronic orthopedic disease that requires reliance on crutches, walkers or a wheelchair that could preclude exercise during the study

Критерии исключения

• Previous use of any device for the treatment of obesity
• Known hepatic disease or biliary disease prior to screening (e.g., viral, autoimmune, fibrosis /cirrhosis etiology, but not including incidental fatty liver)
• Known infection at time of randomization
• Enrolled in another investigational obesity study
• Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet counts less than 100,000/microliter, or known coagulopathy
• Current substance abuse, alcohol or drug addiction
• Chronic pancreatitis or acute pancreatitis within 12 months of randomization
• Diagnosis of autoimmune connective tissue disorder (e.g., lupus erythematosus, scleroderma)
• Type I diabetes
• Hiatal hernia > 3cm
• Presence of ulcer in stomach
• Severe esophagitis (LA classification grade C or D)
• Presence of Barrett's esophagus
• Presence of any other abnormality that impacts the placement of the BariClip®
• Taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (e.g., aspirin, ibuprofen, etc.) within 10 days prior to randomization and/or there is a need or expected need to use during the first 12 months after the index procedure
• Taking prescription antithrombotic therapy (e.g., anticoagulant, or antiplatelet agent) within 10 days prior to randomization and/or there is a need or expected need to use during the first 12 months after the index procedure
• Taking any of the medications on the list of Excluded Medications within 30 days prior to randomization and/or there is a need or expected need to use these medications during the first 12 months after the enrollment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06338709 · 11-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗