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by Chip Hennen Redwood City, CA (August 24, 2009) — EndoGastric Solutions (EGS), the recognized leader in the field of Natural Orifice Surgery (NOS), announced enrollment of the first patients in a clinical trial evaluating the use of StomaphyX to reduce weight regain in patients who have had Roux-en-Y gastric bypass surgery. The StomaphyX clinical trial marks the first randomized, controlled, multicenter study of a medical device to treat weight regain after initial gastric bypass surgery. To date, StomaphyX has been used in over 1,000 procedures conducted by more than 100 surgeons in the United States. It currently has been cleared by the U.S. FDA for tissue approximation, ligation and full-thickness plication in the GI tract. It has been used in a variety of GI procedures to treat fistulas, GERD, dumping and post bariatric surgery pouch dilatation. The FDA-approved, IDE-based randomized controlled trial is expected to enroll 150 patients at two leading academic centers in the United States, University of Pittsburgh Medical Center (UPMC) and The Ohio State University Medical Center (OSUMC), and will compare the StomaphyX device to a sham procedure. The primary endpoint of the study is excess weight loss at twelve months. “StomaphyX appears to be a promising endolumenal alternative to address the need for safer revisional pouch and stoma reduction,” said Dr. Anita Courcoulas, MPH, FACS, Associate Professor of Surgery and Chief of Minimally Invasive Bariatric and General Surgery at UPMC and principal investigator of the study. “The possibility of having an effective minimally invasive treatment option for patients who experience weight regain after their original surgery would represent a marked step forward in post bariatric surgical care. The objective of this trial is of course to study this possibility.” “Our gastric bypass patients in the study are very enthusiastic about the StomaphyX procedure and its potential to help them get back on track with their weight loss,” said Dr. Carol A. McCloskey, Assistant Professor of Surgery at UPMC and co-investigator of the study. “The StomaphyX study’s procedural goal is to reduce the size of an enlarged pouch in patients who originally lost significant weight following gastric bypass but then regained some of it back. Many patients may find the transoral, incisionless StomaphyX procedure appealing when compared to a standard surgical revision because it offers minimal post operative pain, faster recovery time, and no scarring.” Thierry Thaure, President and Chief Executive Officer of EGS, is looking forward to following the study. “We are extremely pleased to announce active enrollment for the StomaphyX clinical trial. This represents a major milestone for EGS. We are excited about having StomaphyX evaluated in a randomized multicenter clinical trial and believe it confirms our position as a leader in the endoluminal bariatric space,” said Thaure. Dr. George M. Eid, Assistant Professor of Surgery at UPMC and co-principal investigator of the study, has been studying endolumenal treatments for revisional weight loss surgery since 2008. “My experience with StomaphyX has been encouraging. We are looking forward to studying the longer term durability of this procedure in our controlled clinical trial.” Study outcomes will be assessed at fixed intervals post procedure with a final endpoint of twelve months. EGS anticipates that enrollment will take six months and that the study will be completed in July 2011, at which time EGS hopes to gain a specific bariatric clearance for its device. For more information on the study, visit www.clinicaltrials.gov. About Revisional Weight Loss Surgery The Roux-en-Y Gastric Bypass (RNYGB) is the most commonly performed bariatric procedure to treat obesity in the U.S. Numerous studies have documented the effectiveness of RNYGB in promoting weight loss after surgery. Despite favorable short-term outcomes of RNYGB, recidivism and weight regain affect approximately 10-40% of patients within two to seven years after the original surgery date. Open and laparoscopic surgical treatments have been used to address weight regain. However, compared with de novo procedures, these treatments are associated with a higher incidence of myriad complications. The high rate of morbidity associated with revisional gastric bypass surgery opens the door for less invasive endoscopic procedures, which may become the preferred approach for weight regain treatment post RNYGB.
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