San Clemente-based USGI Medical Inc has announced that it will be conducting a study to test the effectiveness of its delivery catheter used in incisionless endoscopic bariatric surgery.
The company will be hopeful that the study will lead to its g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors being approved by the US Food and Drug Administration. Around 332 patients from 11 different locations will be selected to take part in its ESSENTIAL study in which the volunteers will be randomly selected to either undergo surgery through g-Cath or sham treatment.
Advertisement"The sham-controlled ESSENTIAL Trial was designed to generate the highest-quality data possible for a procedure. If the outcomes from the POSE procedure are positive and consistent with smaller trials, it could mean that tens of thousands of patients may have an incredibly compelling option to consider if they've struggled to lose weight with diet and exercise, but aren't candidates for or are not prepared to accept the risk of traditional bariatric surgery", lead investigator of the study, Thomas Lavin said.