May 17, 2016 New Multi-Center Registry To Study Benefits of Stretta for GERD Patients after Sleeve Gastrectomy
NORWALK, Conn., May 11, 2016 /PRNewswire/ -- Mederi Therapeutics today announced a new multi-center registry that will study the benefit of Stretta Therapy as a treatment option in patients who experience gastroesophageal reflux disease (GERD) after sleeve gastrectomy (SG).
The study, entitled "Examining the Benefit of RF Treatment (Stretta) of GERD after Sleeve Gastrectomy," includes 15 of the top bariatric programs in the U.S. This multi-center registry will study patients with documented GERD a minimum of six months after a sleeve gastrectomy. The study will focus on GERD symptom control (HRQL) after Stretta, with follow up at six, 12, and 24 months.
Sleeve gastrectomy is the weight loss procedure of choice, representing 51% of bariatric surgeries performed in the U.S. in 2014(up from 42% in 2013). Patients typically choose a sleeve over a gastric bypass because it allows the stomach to retain normal function.
Erin Moran-Atkins, MD, FACS, Principal Investigator and Assistant Professor of Surgery at the Montefiore Medical center and the Albert Einstein School of Medicine, explained the challenges of treating patients with GERD after a sleeve: "Obese patients experience GERD at a dramatically higher rate than the average population. Weight loss surgery resolves GERD in some patients, but for others, symptoms continue. The post-sleeve patient may also have a hard time tolerating common GERD medications and want to avoid a conversion to a gastric bypass, which has been the standard next step."
Co-investigator W. Scott Melvin, MD, FACS, Director General Surgery at the Montefiore Medical Center and Professor of Surgery at the Albert Einstein School of Medicine, further noted the limited options for sleeve patients with GERD. "Because of the sleeve's altered anatomy, you can't perform a fundoplication. Furthermore, conversion to a gastric bypass has a higher complication rate. Stretta has been widely studied in patients with altered anatomy from surgery. Importantly, for the bariatric patient, receiving Stretta doesn't preclude further surgery. We are looking forward to data confirming that Stretta can help the growing bariatric patient population with GERD."
Studies show that up to 84% of patients with pre-existing GERD continued to have symptoms after a sleeve gastrectomy, and at least eight percent develop new GERD post-operatively.
Stretta is a non-surgical procedure for GERD that uses radiofrequency (RF) energy to regenerate the muscle between the stomach and esophagus. Studies show that Stretta resolves reflux symptoms, improves quality of life, reduces or eliminates medications, and decreases acid exposure in patients with chronic GERD. Stretta is delivered transorally and does not alter the anatomy, making it a viable option for patients with GERD who have undergone bariatric surgery.
Stretta is a versatile, non-surgical option for GERD patients who do not respond well to medications and wish to avoid surgery. Stretta has been the subject of more than 40 studies, all showing a high level of safety and efficacy. Manufactured by Mederi Therapeutics, Stretta is available worldwide.
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Contact: Mike Elofer