December 22, 2014
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AGA: First patients enrolled in GERD registry

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The first patients enrolled in the American Gastroenterology Association’s national observational registry have successfully undergone transoral incisionless fundoplication treatment, according to a press release.

“This is an important milestone in [American Gastroenterology Association’s] endeavor to develop national observational registries to help bring new medical devices and treatments to physicians and their patients in an efficient, safe and meaningful way,” Ashish Atreja, MD, MPH, chair of the registry oversight subcommittee of the American Gastroenterology Association (AGA) Center for GI Innovation and Technology, said in the release. “With each patient, we will collect valuable data evaluating safety, efficacy and comparative outcomes. The goal of this registry is to provide the entire health care system — patients, payors, purchasers and providers — with evidence to back future technology decisions.”

Ashish Atreja, MD, MPH

Ashish Atreja

According to the release, the AGA Center for GI Innovation and Technology partnered with EndoGastric Solutions to develop the STAR Registry, which aims to compare laparoscopic surgery with an incisionless procedure to treat GERD. The registry will provide the first real-world data on patient outcomes with laparoscopic Nissen fundoplication vs. transoral incisionless fundoplication with EndoGastric Solutions’ EsophyX device, the release said. The first two patients have undergone transoral incisionless fundoplication at Lenox Hill Hospital in New York, under the care of Anthony A. Starpoli, MD, associate director of esophageal endotherapy, and Gregory B. Haber, MD, and at SurgOne Foregut Institute in Englewood, Colo., under the care of Reginald Bell, MD, founder of SurgOne Foregut Institute, the release said. Data from these and all patients enrolled in the registry will be obtained from standard follow-up appointments and check-ins from the registry staff every 6 months for approximately 3 years after the procedure. This data will be used to compare efficacy, safety, side effects and costs.

“GERD is a deceptively complex condition, and the most commonly used treatment options may not adequately serve all patients,” Starpoli said in the release. “I’m honored to support the collection of data that will be used to evaluate the durability and safety of this technology, which could provide a new evidence-based treatment option for patients suffering from GERD.”

“By participating in this national observational registry, we are collecting important data that will improve the future of GERD treatment,” Bell said in the release. “As a physician, I’m thrilled to know that I will have access to long-term efficacy data about patients who choose surgical therapy for GERD, which is invaluable to patient care decisions.”