USGI Medical will enroll up to 350 patients in an FDA-approved clinical trial of the g-Cath EZ suture anchor delivery catheter, an incision-free bariatric surgery technology that has already been used on more than 2,000 patients, mostly in Europe.

The San Clemente, Calif.-based device maker won conditional FDA investigational device exemption to launch the study, which USGI "believes to be the largest multi-center, randomized, sham-controlled study of an endoscopic procedure for weight loss ever conducted."

The g-Cath EZ system is delivered through the mouth and into the stomach, where it creates folds in strategically located areas, suturing them off to reduce the overall size of the stomach, lessening its capacity to hold food. The device has been used "extensively" for non-obesity indications, USGI said, and it’s the 1st device of its kind to demonstrable create durable, healed folds in the stomach.

The ESSENTIAL clinical trial will include up to 9 centers across the U.S., where it patients will receive treatment on an out-patient basis.

"Surgery for weight loss has been studied with positive results, but this will be one of 1st first major trials to prospectively compare the effectiveness of an endoscopic procedure against a sham procedure plus diet and exercise," investigator Dr. Thomas Lavin said in prepared remarks on behalf of the company. "Based on preliminary studies conducted in Europe, we believe that this new approach may help patients feel full sooner during meals, improving satiety and reducing hunger cravings so they can control their portions, consume fewer calories and lose weight."