Prospective, Randomized Clinical Study Evaluating Transoral Outlet Reduction (TORe) and Lifestyle Modification for Patients With Weight Regain Following Roux-en-Y Gastric Bypass
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 16
- 主要终点
- Total Body Weight Loss
研究概览
简要总结
The goal of this clinical trial is to evaluate weight loss with TORe and intensive lifestyle modification versus intensive lifestyle modification alone in subjects who have regained weight following a Roux-en-Y gastric bypass.
Participants will randomized 2:1. Those randomized to the TORe arm will receive a TORe procedure and intensive lifestyle modification which consists of a well-balanced calorie restrictive diet, incorporation of exercise and coaching on lifestyle discussion. Participants randomized the lifestyle modification alone arm will be eligible to receive a TORe procedure at 6 months post enrollment. Total follow up will be 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older.
- •Experiencing weight regain (≥ 20% weight from nadir) after achieving clinically successful weight loss.
- •Willing to have a TORe procedure for the treatment of weight regain.
- •BMI between 30 and 50 kg/m2, inclusive.
- •GJA diameter ≥ 20 mm, confirmed either during a
- •Screening EGD completed ≤ 60 days from study procedure or
- •EGD performed immediately prior to the TORe procedure.
- •Anatomically accepting of the procedure, including a pouch size that will not require reduction at the time of treatment (pouch that is shorter than 6 cm in length).
- •Agrees not to take additional over the counter or prescribed weight loss supplements / medications (including incretins) during the first 6 months of the study.
- •Is on a stable dose of anti-diabetic medication for three months with no anticipated changes during the first 6 months of the study.
- •Agrees to the follow-up requirements of the study and is able to read, understand, and sign a written Informed Consent Form to participate in the study.
- •Meets the indications for TORe procedure with OverStitch™ Endoscopic Suturing System.
排除标准
- •Current use or use within the three months prior to the baseline visit of over the counter or prescribed weight loss supplements / medications (including incretins).
- •Current or planned management of Type 2 Diabetes with incretin medications.
- •Inability or unwillingness to comply with assigned treatment or protocol requirements related to visits.
- •Investigator's medical judgement that the subject is not a candidate for the TORe procedure.
- •Current pregnancy confirmed by site standard of care or planned pregnancy or breastfeeding in the next two years.
- •Vulnerable subject.
研究组 & 干预措施
Lifestyle Modification Arm
Subjects will receive intensive lifestyle modification throughout the study. At 6 months post enrollment, subjects will be eligible to receive a TORe procedure.
干预措施: Intensive lifestyle modification (Behavioral)
TORe and Lifestyle Modification Arm
Subjects will receive a TORe procedure and intensive lifestyle modification throughout the study
干预措施: TORe with OverStitch (Device)
TORe and Lifestyle Modification Arm
Subjects will receive a TORe procedure and intensive lifestyle modification throughout the study
干预措施: Intensive lifestyle modification (Behavioral)
结局指标
主要结局
Total Body Weight Loss
时间窗: 6 Months post enrollment
The percent TBWL that subjects achieve at 6 months post-randomization
次要结局
- Clinically significant weight loss(6, 12 and 24 months post enrollment)
- Change in Alanine transaminase (ALT)(6, 12, 18, and 24 months post enrollment)
- Change in Aspartate aminotransferase (AST)(6, 12, 18, and 24 months post enrollment)
- Percent TBWL at each visit(6 months post enrollment and through end of study)
- Change in A1C(6, 12, 18, and 24 months post enrollment)
- Change in Insulin(6, 12, 18, and 24 months post enrollment)
- Change in Fasting Glucose(6, 12, 18, and 24 months post enrollment)
- Change in Cholesterol(6, 12, 18, and 24 months post enrollment)
- Change in Alkaline phosphatase (ALP)(6, 12, 18, and 24 months post enrollment)
- Reduction in Medications for Type 2 diabetes(6, 12, 18 and 24 months post enrollment)
- Change in 36-Item Short Form Survey (SF-36) Quality of Life Questionnaire(6, 12, 18, and 24 months post enrollment)
- Change in LDL(6, 12, 18, and 24 months post enrollment)
- Change in HDL(6, 12, 18, and 24 months post enrollment)
- Change in Triglycerides(6, 12, 18, and 24 months post enrollment)
- Reduction in cholesterol medication(6, 12, 18 and 24 months post enrollment)
- Reduction in Hypertension Medication(6, 12, 18 and 24 months post enrollment)
- Reduction in medications for dumping syndrome(6, 12, 18 and 24 months post enrollment)
- Number of device and procedure-related Adverse Events (AEs) and Serious Adverse Events (SAEs)(From enrollment through 24 months (study completion))
- Change in Sigstad Score(6, 12, 18, and 24 months post enrollment)
- Change in Impact of Weight on Quality of Life (IWQOL LITE-CT) Quality of Life Questionnaire(6, 12, 18, and 24 months post enrollment)