A RANDOMIZED, SUBJECT AND EVALUATOR-BLINDED, PARALLEL-GROUP, MULTICENTER CLINICAL TRIAL USING AN ENDOSCOPIC SUTURING DEVICE (G-CATH EZ™ SUTURE ANCHOR DELIVERY CATHETER) FOR PRIMARY WEIGHT LOSS

USGI Medical11 sites in 1 country377 target enrollmentDecember 1, 2013

ConditionsObesity

Overview

Phase: N/A
Intervention: Not specified
Conditions: Obesity
Sponsor: USGI Medical
Enrollment: 377
Locations: 11
Primary Endpoint: Total Body Weight Loss
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled study intended to evaluate the safety and efficacy of treating obese patients with the placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as compared to a sham procedure followed by the same diet and exercise plan. Subjects will be randomly assigned in a 2:1 ratio to the treatment procedure followed by diet and exercise or the sham procedure followed by diet and exercise. After un-blinding at 12 months post-treatment, sham patients can choose to have the treatment procedure as well.

Registry

clinicaltrials.gov

Start Date

December 1, 2013

End Date

August 1, 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

USGI Medical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provide written informed consent.
•Be male or female subjects between the ages of 22-60 years.
•If female, be either post-menopausal, surgically sterile or agree to practice birth control during year of study and have negative serum HCG at screening and baseline.
•Have a Body Mass Index (BMI) of ≥30 and \<35 with at least one non-severe co-morbid obesity related condition or a BMI ≥ 35 and \< 40 with or without a non-severe obesity related co-morbid condition, where a severe co-morbid condition is defined as severe if symptoms cause severe discomfort, performance of daily activities is compromised, and/or condition is not entirely controlled with prescription drug therapy.
•Have had no significant weight change (+/- 5% of total body weight) in last 6 months.
•Have an American Society Anesthesiologists-PS score ≤ 2 (Appendix III).
•Agrees not to have any additional weight loss interventional procedures, liposuction, or take any over the counter or prescription weight loss medication for 24 months following study enrollment.
•Have not taken any prescription or over the counter weight loss medications for at least 6 months and agrees not to utilize for 12 months following study enrollment.
•Be willing to cooperate with post-operative dietary recommendations and assessment tests.
•Reside within a reasonable distance from the Investigator's treating office (\~50 miles) and able and willing to travel to the Investigator's office to complete all routine follow-up visits.

Exclusion Criteria

•History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
•Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments.
•Severe gastro-esophageal 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.
•Large hiatal hernia (\>3 cm) by history or as determined by pre-randomization endoscopy.
•Pancreatic insufficiency/disease.
•Active gastric erosions or gastric/duodenal ulcer.
•History of gastroparesis or symptoms that would be suggestive of gastroparesis.
•Pregnancy or plans of pregnancy in the next 12 months.
•Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 1 month of Visit
•Intranasal/inhaled steroids are acceptable.

Outcomes

Primary Outcomes

Total Body Weight Loss

Time Frame: Enrollment to 12 months

Evaluate the effectiveness of the g-Cath EZ™ Suture Anchor Delivery Catheter (USGI Medical, San Clemente, CA, USA) with diet and exercise as an early weight loss intervention for Class I obesity subjects with at least one non-severe obesity related co-morbid condition or Class II obesity subjects with or without a non-severe obesity related co-morbid condition compared to a sham procedure, diet and exercise group.