AGA) Center for GI Innovation and Technology is pleased to announce that the first two enrollees in the STAR Registry

Dec 23 2014

The American Gastroenterological Association (AGA) Center for GI Innovation and Technology is pleased to announce that the first two enrollees in the STAR Registry — which seeks to compare laparoscopic surgery to an incisionless procedure to treat gastroesophageal reflux disease (GERD) — have successfully undergone treatment.

“This is an important milestone in AGA’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,” said Ashish Atreja, MD, MPH, chair of the registry oversight subcommittee of the AGA Center for GI Innovation and Technology.

“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.”

As a neutral objective broker, the AGA Center for GI Innovation and Technology has partnered with EndoGastric Solutions® to establish the STAR Registry (Laparoscopic Nissen Fundoplication (LNF) Surgery Versus Transoral Incisionless Fundoplication (TIF®): Anti-Reflux Treatment Registry). The STAR Registry will provide the first real-world data observing patient outcomes following laparoscopic surgery and transoral fundoplication with the EsophyX® device. Transoral fundoplication is an incisionless procedure that allows physicians to reshape the anti-reflux valve that prevents stomach acid and contents from flowing up into the esophagus. Both of the surgical procedures for GERD examined in the STAR Registry are performed with FDA-cleared devices and techniques.

The first two patients, who underwent incisionless fundoplication, were treated at:
Lenox Hill Hospital in New York, NY, under the care of Anthony A. Starpoli, MD, and Gregory B. Haber, MD.

SurgOne Foregut Institute in Englewood, CO, under the care of Reginald Bell, MD.
“GERD is a deceptively complex condition and the most commonly used treatment options may not adequately serve all patients,” said Dr. Starpoli, associate director of esophageal endotherapy at Lenox Hill Hospital. “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,” said Dr. Bell, founder of SurgOne Foregut Institute. “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.”

As with all patients enrolled in the registry, data from the first two patients will be collected from standard follow up appointments with the patients, and the registry staff will also check in with the patients every six months for approximately three years following the GERD procedure. Researchers will use this data to compare effectiveness, safety, post-operative side effects or post-procedure costs associated with episodes of care and any ensuing complications.

The STAR Registry is AGA’s first national observational registry. The AGA Center for GI Innovation and Technology does not endorse any product or service, develop guidelines, nor make any guarantees about FDA approval or coverage from public or private payors.