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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Multicenter Feasibility Study of an IncisionLEss Operating Platform for Primary ObeSiTy vs. Diet-exercise Alone: The MILEPOST Study

Conditions
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Obesity

Intervention / Treatment
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* Device: g-CathTM EZ Suture Anchor Delivery Catheter
* Other: Diet and Exercise Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: g-Cath EZ Treatment Group<br>Evaluate the safety and effectiveness of the g-CathTM EZ Suture Anchor Delivery Catheter as an early weight loss intervention | Device: g-CathTM EZ Suture Anchor Delivery Catheter<br>* 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<br>|
| Active Comparator: Diet and exercise Control Group<br>Diet and Exercise only control group | Other: Diet and Exercise Control Group<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint | Incidence and severity of Adverse Events [AE] over 12 Months | 12 months | 
| Primary Efficacy Endpoint | Mean % TBWL at 12 months for Treatment subjects compared to Control subjects | 12 months | 
| Co-Primary Efficacy Endpoint | The proportion of Treatment subjects achieving ≥ 5% TBWL at 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Secondary Efficacy Endpoint | Mean % TBWL at 24 months. | 24 months | 
| Second Secondary Efficacy endpoint | Proportion of subjects achieving ≥ 5% TBWL at 24 months | 24 months | 
| Third Secondary Efficacy endpoint | Satiety changes (volume and time to satiety at 2, 6, 12 months post-procedure) | 2, 6, 12 months | 
| Fourth Secondary Efficacy endpoint | % Estimated Weight Loss [EWL] at 12 months and 18 months [% EWL will be calculated using BMI-25 criteria] | 12 & 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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g-Cath EZ Suture Anchor Delivery Catheter, Weight Loss Intervention