Use of the Incisionless Operating Platform as a Primary Treatment for Obesity vs. Diet-Exercise Alone (MILEPOST)

USGI Medical

Status

Unknown

Conditions

Obesity

Treatments

Device: g-CathTM EZ Suture Anchor Delivery Catheter

Other: Diet and Exercise Control Group

Study type

Interventional

Funder types

Industry

Identifiers

NCT01843231

41936

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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