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FDA Gives Nod for Expansion of USGI’s Pilot Study

The study is set to evaluate POSE 2.0, an incisionless weight loss procedure.

FDA has approved an expansion of a pilot study from USGI Medical’s POSE 2.0 non-invasive endoscopic procedure to treat obesity.

The San Clemente, CA-based company said the expansion allows for the trial to enroll 35 patients at four U.S. institutions.

POSE 2.0 uses USGI Medical’s Incisionless Operating Platform (IOP) to strategically place durable Snowshoe Suture Anchors in gastric tissue to both shorten and narrow the stomach. The procedure provides volumetric gastric restriction, like that achieved by a surgical sleeve gastrectomy, without amputating part of the stomach. 

Patients treated with the POSE procedure typically return to work in just one to two days without any scars or signs of surgery.

During the first stage of the US pilot study, Principal Investigator, Professor Barham Abu Dayyeh, MD, MPH at the Mayo Clinic (Rochester, MN) treated five patients with the POSE 2.0 procedure. Participants in the IDE study are evaluated for weight loss and other efficacy assessments and receive lifestyle and nutritional care through the primary endpoint of one year.

In a release, Dr. Abu Dayyeh said, “This procedure is very reproducible. It’s quite impressive how every patient receives the same new smaller stomach configuration throughout the series contributing to ease of use and consistent positive results.”

To date at the midpoint follow-up of six months, patients treated with the POSE 2.0 procedure achieved on average 12.5% total body weight loss (TBWL). All patients responded to treatment with a clinically meaningful TBWL >5% and 60% of patients achieved TBWL >13%. Thus far, all patients are fully satisfied with their outcomes to date and no adverse events were reported during both the procedure as well as throughout the 6-month follow-up.

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