USGI Medical, a California-based devicemaker focused on incisionless, endoscopic procedures for weight loss, reflux and advanced therapeutic endoscopy, said enrollment has been completed for a pivotal study to evaluate the company's POSE (Primary Obesity Surgery, Endolumenal) procedure.
Last October, the FDA gave conditional investigational device exemption (IDE) approval to USGI to begin enrollment. The company said it has signed up 332 patients at 11 U.S. sites for its ESSENTIAL trial. The study will be randomized and sham-controlled. Participating patients will use USGI's g-Cath EZ Suture Anchor Delivery Catheter to place tissue anchors across folds of tissue in certain parts of the stomach in order to reduce its size and ability to stretch to accommodate a meal.
"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," Thomas Lavin, the lead investigator of the study, said in a statement.
Surgeons have already performed the incisionless, outpatient procedure on more than 2,000 patients, mostly in Europe, working through the mouth. Patients return to work, bandage-free, within two to three days. In one study conducted in Spain, patients who had the procedure reported feeling full quicker and less hungry between meals, the company said. A year after the procedure, those patients lost 62% of their excess weight, on average, or over 19% of their total body weight.
USGI is one of several obesity device companies aiming for a U.S. approval. Earlier this week, Aspire Bariatrics announced it had completed enrollment of a pivotal trial for its AspireAssist Aspiration Therapy, and ReShape Medical recently submitted a PMA to the FDA for its balloon-based obesity device, while EnteroMedics garnered a mixed FDA panel vote in June for its neurostimulator obesity device. EndoBarrier is also in pivotal trials for its endoscopic obesity device.
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