A Randomized Controlled Multicenter Feasibility Study of an IncisionLEss Operating Platform for Primary ObeSiTy vs. Diet-exercise Alone: The MILEPOST Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
This study is a multi-center, open/unblended study (3:1Treatment: Control) to evaluate the safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight loss intervention compared to a diet and exercise control only. Mean % Total Body Weight Loss [TBWL] in Treatment subjects versus that of Control subjects at 12 months is the primary endpoint. The proportion of subjects achieving ≥ 5% TBWL at 12 months in the treatment group is a co-primary endpoint.
详细描述
This study will evaluate the safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight loss intervention compared to a diet and exercise control only. The weight loss outcomes will be used to assess treatment effect. This study is a multi-center, open/unblinded, prospective randomized feasibility study (3:1Treatment: Control) study. Patients in the control group will be offered the opportunity to crossover to the treatment group at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-60 years
- •Body Mass Index [BMI] of >30 and <40 with or without a co-morbid condition
- •Subject has failed more conservative weight reduction alternatives such as supervised diet, exercise or behavior modification programs in the last year
- •No significant weight change (+/- 5% of total body weight) in last 6 months
- •American Society Anesthesiologists-Physical Status score ≤ 2 (Appendix III),
- •Subject agrees not to have any additional weight loss interventional procedures or liposuction for at least 30 months following study enrollment,
- •Has not taken any prescription or over the counter weight loss medications for at least 6 months,
- •Signed informed consent.
- •Subject is willing to cooperate with post-operative dietary recommendations and assessment tests,
排除标准
- •History of (or intraoperative evidence of) bariatric, gastric or esophageal surgery
- •Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments
- •Severe gastroesophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with prescription drug therapy
- •Known hiatal hernia >3 centimeters by history or as determined by Upper Gastrointestinal exam or endoscopy
- •Pancreatic insufficiency/disease
- •Active peptic ulcer
- •Pregnancy or plans of pregnancy in the next 12 months
- •Present Corticosteroid Use
- •History of inflammatory disease of Gastrointestinal [GI] tract; Coagulation disorders; hepatic insufficiency or cirrhosis
- •History or present use of insulin or insulin derivatives for treatment of diabetes
- •Type II Diabetes Mellitus [DM] (as defined by Glycosylated Hemoglobin [HgbA1c] >6.5) for greater than 2 years at the time of enrollment
- •Uncontrolled Type II DM (HgbA1c > 7.0 at screening)
- •Quit smoking within last 6 months at time of enrollment or plans to quit smoking in the next year
- •Immunosuppression
- •Portal hypertension and/or varices
- •Active gastric ulcer disease
- •Gastric outlet obstruction or stenosis
- •Beck Depression Inventory (Short) Score ≥12 (see Appendix IV);
- •Subject has a history of drug or alcohol abuse or actively abusing either as defined by Cage and DAST [drug use] questionnaires or positive Urinalysis [UA] drug screen
- •Severe disturbances in eating behavior (i.e. binge eating)
- •Known presence of a significant depression, psychosis, or other mood or eating disorder
- •Actively treated depression (except for stable treated depression for >1year and normal [Beck Depression Inventory [BDI] and psych exam)
- •Present or past history of psychosis or other mood or eating disorder
- •Non-ambulatory or has significant impairment of mobility
- •Known hormonal or genetic cause for obesity with the exception of treated hypothyroidism.
- •Participating in another clinical study
- •Is a first degree relative of investigator, or support staff involved in the study.
- •Employed by investigator or institution involved in the study
- •Subject is not able to provide written informed consent
结局指标
主要结局
Primary Safety Endpoint
时间窗: 12 months
Incidence and severity of Adverse Events \[AE\] over 12 Months
Co-Primary Efficacy Endpoint
时间窗: 12 months
The proportion of Treatment subjects achieving ≥ 5% TBWL at 12 months
Primary Efficacy Endpoint
时间窗: 12 months
Mean % TBWL at 12 months for Treatment subjects compared to Control subjects
次要结局
- Third Secondary Efficacy endpoint(2, 6, 12 months)
- Second Secondary Efficacy endpoint(24 months)
- First Secondary Efficacy Endpoint(24 months)
- Fourth Secondary Efficacy endpoint(12 & 18 months)