A Randomized Controlled Multicenter Feasibility Study of an IncisionLEss Operating Platform for Primary ObeSiTy vs. Diet-exercise Alone: The MILEPOST Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- USGI Medical
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- Primary Safety Endpoint
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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,
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Primary Safety Endpoint
Time Frame: 12 months
Incidence and severity of Adverse Events \[AE\] over 12 Months
Co-Primary Efficacy Endpoint
Time Frame: 12 months
The proportion of Treatment subjects achieving ≥ 5% TBWL at 12 months
Primary Efficacy Endpoint
Time Frame: 12 months
Mean % TBWL at 12 months for Treatment subjects compared to Control subjects
Secondary Outcomes
- 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)