NL-OMON40379
Completed
Phase 3
A Randomized Controlled Multicenter Study of an Incisionless Operating Platform for Primary Obesity vs. Diet-Exercise alone: The MILEPOST Study - MILEPOST
SGI Medical, Inc0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- SGI Medical, Inc
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Age 20\-60 years
- •\* BMI of \>30 and \<40 with or without a co\-morbid condition
- •\* Patient 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\-PS score \* 2 (Appendix III)
- •\* Has not taken any prescription or over the counter weight loss medications for at least 6 months
- •\* Subject agrees not to have any additional weight loss interventional procedures or liposuction for at least 30 months following study enrollment,
- •\* Subject is willing to cooperate with post\-operative dietary recommendations and assessment tests
- •\* Signed informed consent
Exclusion Criteria
- •\* History of (or intra\-operative evidence of) bariatric, gastric or esophageal surgery
- •\* Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments
- •\* Severe Gastro\-esophageal 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 \>3cm by history or as determined by UGI 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 GI tract; coagulation disorders; hepatic insufficiency or cirrhosis
- •\* History or present use of insulin or insulin derivatives for treatment of diabetes
Outcomes
Primary Outcomes
Not specified
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