use of the incisionless operating platform as a primary treatment for obesity vs. diet-exercise alone

Conditions: Obesity

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.

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.

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 * 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

Keywords: g-cath ez suture anchor delivery catheter weight loss intervention