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Stretta Registry

Registry to assess Stretta Therapy for GERD after LSG

This multi-centre registry will study patients with documented GERD a minimum of six months after a sleeve gastrectomy.

Mederi Therapeutics has announced a new multi-centre registry that will study the benefit of Stretta Therapy as a treatment option in patients who experience gastroesophageal reflux disease (GERD) after laparoscopic sleeve gastrectomy (SG). The study, entitled "Examining the Benefit of RF Treatment (Stretta) of GERD after Sleeve Gastrectomy," includes 15 of the top bariatric programmes in the US. This multi-centre 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.

"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,” said Erin Moran-Atkins, Principal Investigator and Assistant Professor of Surgery at the Montefiore Medical center and the Albert Einstein School of Medicine. “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."

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.

"Because of the sleeve's altered anatomy, you can't perform a fundoplication. Furthermore, conversion to a gastric bypass has a higher complication rate,” said Co-investigator, Dr W Scott Melvin, Director General Surgery at the Montefiore Medical Center and Professor of Surgery at the Albert Einstein School of Medicine. “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."

Stretta is a non-surgical procedure for GERD that uses radiofrequency (RF) energy to regenerate the muscle between the stomach and oesophagus. The company stated that 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 therapy delivers low power, low temperature radiofrequency energy to remodel the valve known as the lower oesophageal sphincter (LES) at the junction of the oesophagus and the stomach. Stretta reduces or eliminates regurgitation of stomach contents by improving muscle tone and reducing random openings of the LES that are known to cause GERD. Stretta treatment results in elimination or significant reductions of GERD symptoms and medication use, and significant improvement in a patient's quality of life. (Credit: PRNewsFoto/Mederi Therapeutics Inc.)

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. 

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