SAN CLEMENTE, Calif., July 9, 2014 /PRNewswire/ -- USGI Medical, Inc., a company pioneering research in the area of incisionless, endoscopic procedures for weight loss, reflux and advanced therapeutic endoscopy, announced that on June 9, 2014, enrollment was completed for the ESSENTIAL Trial™, a U.S.-based pivotal study designed to prospectively compare weight loss results between an endoscopic procedure and a sham procedure. The endoscopic procedure is known as POSE™ (Primary Obesity Surgery, Endolumenal). The ESSENTIAL Trial is one of the largest multicenter, randomized, sham-controlled studies of an endoscopic procedure for weight loss ever conducted.
A total of 332 patients at 11 sites across the U.S. are participating in the investigational device exemption (IDE) study. Patients enrolled in the trial will be followed for weight loss and other efficacy endpoints for a year and receive a total of at least two years of follow up and nutritional care. The study will form the basis of the company's marketing application with the FDA seeking approval for a weight loss indication in the labeling for the g-Cath™ EZ Delivery Catheter with Snowshoe™ Suture Anchors. All of the components of the USGI's Incisionless Operating Platform™ currently have U.S. 510(k) clearance and CE Mark.
"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," said Thomas E. Lavin, MD, FACS, FASMBS, founder of The Surgical Specialists of Louisiana and the Lead Investigator in the study. "Based on preliminary studies of the POSE procedure 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."
Globally, more than 2,500 patients have undergone the POSE procedure and most of these patients returned to work without any bandages or signs of surgery within two to three days. In one study, patients treated at a center in Spain reported feeling full faster and less hungry between meals after undergoing the POSE procedure. A year after the procedure, patients had lost 62% of their excess weight, on average or over 19% of their total body weight. In Europe, the procedure is generally performed in an outpatient setting.
"Completing enrollment in our U.S. pivotal study marks a significant milestone for the company," said James White, D.O., Vice President of Medical Affairs for USGI. "We are fortunate to have partnered with such an incredible and diverse investigative team of U.S. obesity experts and institutions. We will continue to work with the ESSENTIAL Trial investigators and their teams to ensure the highest quality safety and outcomes for the subjects in the study. The official efficacy analysis ends after the patients' one-year follow up appointments, at which time we will work in earnest to complete our marketing application for submission to the FDA for an obesity indication in our label."
Physicians participating in the study used the company's Incisionless Operating Platform™ to place tissue anchors across folds of tissue in strategically-located parts of the stomach to reduce its size and ability to stretch to accommodate a meal. The USGI g-Cath™ EZ Delivery Catheter with Snowshoe™ Suture Anchors, which is used extensively for general, non-obesity indications, is the first endoscopic suturing technology proven to create a durable, healed fold in the stomach.
About USGI Medical, Inc.
USGI Medical is committed to the development of technologies to enable Incisionless Surgery – the treatment of diseases through the natural passageways of the body. USGI's Incisionless Operating Platform provides surgeons the operating platform and specialized tools they need to perform surgery through a patient's mouth or other natural orifices, reducing the need for external incisions into the abdomen. Importantly, USGI has demonstrated the capability to reliably and durably approximate GI tract tissue without an incision. Operating through the body's natural orifices offers promise for less pain, shorter hospital stays, reduced risk of wound infection and no external scars – and is rapidly becoming an option demanded by patients and healthcare providers. USGI offers surgeons and gastroenterologists the tools they need to offer millions of potential patients a less invasive surgical option. For more information, go to http://www.usgimedical.com/.
The Incisionless Operating Platform, including the g-Cath EZ Delivery Catheter with Snowshoe™ Suture Anchors has both CE Mark and US 510(k) Clearance. As a treatment for obesity, however, it is considered an investigational device in the United States and is thereby limited by Federal Law to investigational use for this application.
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SOURCE USGI Medical, Inc.