Obesity
Conditions
Keywords
g-Cath EZ Suture Anchor Delivery Catheter, Weight Loss Intervention
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.
Interventions
DEVICEg-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
OTHERDiet 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
Sponsors
USGI Medical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | 12 months | Incidence and severity of Adverse Events \[AE\] over 12 Months |
| Primary Efficacy Endpoint | 12 months | Mean % TBWL at 12 months for Treatment subjects compared to Control subjects |
| Co-Primary Efficacy Endpoint | 12 months | The proportion of Treatment subjects achieving ≥ 5% TBWL at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 \[% EWL will be calculated using BMI-25 criteria\] |
| 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) |
Countries
Austria, Netherlands, Spain
Outcome results
None listed