Overview

This trial is active, not recruiting.

Condition obesity
Treatments g-cathtm ez suture anchor delivery catheter, diet and exercise control group
Sponsor USGI Medical
Start date September 2013
End date August 2015
Trial size 40 participants
Trial identifier NCT01843231, 41936

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Evaluate the safety and effectiveness of the g-CathTM EZ Suture Anchor Delivery Catheter as an early weight loss intervention
g-cathtm ez suture anchor delivery catheter
Use of the g-Cath EZ Suture Anchor Delivery Catheter for the placement of g-cath EZ suture anchors as an early weight loss intervention + diet and exercise as compared to those in the diet and exercise control group
(Active Comparator)
Diet and Exercise only control group
diet and exercise control group
Patients in a diet and exercise only control group that will be compared to those in the g-Cath EZ Suture Anchor Delivery Catheter treatment group

Primary Outcomes

Measure
Primary Safety Endpoint
time frame: 12 months
Primary Efficacy Endpoint
time frame: 12 months
Co-Primary Efficacy Endpoint
time frame: 12 months

Secondary Outcomes

Measure
First Secondary Efficacy Endpoint
time frame: 24 months
Second Secondary Efficacy endpoint
time frame: 24 months
Third Secondary Efficacy endpoint
time frame: 2, 6, 12 months
Fourth Secondary Efficacy endpoint
time frame: 12 & 18 months

Eligibility Criteria

Male or female participants from 20 years up to 60 years old.

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

Additional Information

Official title A Randomized Controlled Multicenter Feasibility Study of an IncisionLEss Operating Platform for Primary ObeSiTy vs. Diet-exercise Alone: The MILEPOST Study
Principal investigator Jorge C. Espinos, Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by USGI Medical.