A Randomized Controlled Multicenter Study of an Incisionless Operating Platform for Primary Obesity vs. Diet-Exercise alone: The MILEPOST Study
- Conditions
- Obesityoverweight10017998
- Registration Number
- NL-OMON40379
- Lead Sponsor
- SGI Medical, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
* 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
* 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
* Type II Diabetes Mellitus (as defined by 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 questionnaires or positive 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 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 or relative of same
* Subject is not able to provide written informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary efficacy hypotheses:<br /><br>* Mean %TBWL in the Treatment group will be * 5 % higher than the Control group<br /><br>at 12 months<br /><br>* The proportion of subjects achieving * 5% total body weight loss at 12 months<br /><br>will be >50% in Treatment group</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary efficacy hypotheses:<br /><br>* The proportion of patients achieving improvement of quality of life at 12<br /><br>months will be larger in the Treatment group than in the Control group<br /><br>* There will be significant differences in both time to satiety and caloric<br /><br>capacity in the Treatment group as compared to the Control group at all<br /><br>time-points following the intervention</p><br>