Use of the Incisionless Operating Platform as a Primary Treatment for Obesity vs. Diet-Exercise Alone
- Conditions
- Obesity
- Interventions
- Other: Diet and Exercise Control GroupDevice: g-CathTM EZ Suture Anchor Delivery Catheter
- Registration Number
- NCT01843231
- Lead Sponsor
- USGI Medical
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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,
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Diet and exercise Control Group Diet and Exercise Control Group Diet and Exercise only control group g-Cath EZ Treatment Group g-CathTM EZ Suture Anchor Delivery Catheter Evaluate the safety and effectiveness of the g-CathTM EZ Suture Anchor Delivery Catheter as an early weight loss intervention
- Primary Outcome Measures
Name Time Method Primary Safety Endpoint 12 months Incidence and severity of Adverse Events \[AE\] over 12 Months
Co-Primary Efficacy Endpoint 12 months The proportion of Treatment subjects achieving ≥ 5% TBWL at 12 months
Primary Efficacy Endpoint 12 months Mean % TBWL at 12 months for Treatment subjects compared to Control subjects
- Secondary Outcome Measures
Name Time Method Second Secondary Efficacy endpoint 24 months Proportion of subjects achieving ≥ 5% TBWL at 24 months
Third Secondary Efficacy endpoint 2, 6, 12 months Satiety changes (volume and time to satiety at 2, 6, 12 months post-procedure)
First Secondary Efficacy Endpoint 24 months Mean % TBWL at 24 months.
Fourth Secondary Efficacy endpoint 12 & 18 months % Estimated Weight Loss \[EWL\] at 12 months and 18 months \[% EWL will be calculated using BMI-25 criteria\]
Trial Locations
- Locations (3)
Krakenhaus Hallein
🇦🇹Hallein, Salzburg, Austria
Centro Medico Teknon
🇪🇸Barcelona, Spain
Atrium Medical Centre
🇳🇱Heerlen, Netherlands