Bethesda, MD — 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.
- Read about AGA’s device registry initiative.
- Information for companies and GIs on how to get involved in AGA’s observational research device registries.
- Read the March 2014 press release announcing the STAR Registry.
- Read AGA’s patient brochure on GERD.
About the AGA Institute
About EndoGastric Solutions®
EndoGastric Solutions (EGS), Inc. (www.endogastricsolutions.com), headquartered in San Mateo, California, is a leader in the endoluminal treatment of digestive diseases. EGS’ mission is to combine the most advanced concepts in gastroenterology and surgery to develop products and procedures that address unmet needs in gastrointestinal diseases.
About EsophyX® and Transoral Incisionless Fundoplication (TIF®)
The EsophyX device was FDA cleared in 2007, and is commercially available in the United States. Inserted transorally with visual guidance from an endoscope, the EsophyX device is used in the TIF procedure to reconstruct the gastroesophageal valve, restoring its competency and reestablishing the barrier to reflux. The TIF procedure is a surgical solution that corrects the root cause of GERD. The TIF procedure is based on traditional surgical principles and offers similar effectiveness to a surgical repair with the safety profile of an incision-free approach. To date, more than 16,000 patients have been treated worldwide. For more information, visit www.GERDHelp.com.
About Lenox Hill Hospital
Lenox Hill Hospital, a member of the North Shore-LIJ Health System, is a 652-bed, fully accredited, acute care hospital located on Manhattan’s Upper East Side with a national reputation for outstanding patient care and innovative medical and surgical treatments. US News & World Report has ranked the hospital among the nation’s top 50 in Cardiology and Heart Surgery, and Ear, Nose and Throat, and among the top 10 hospitals in the state of New York with a total of 10 “high performing” designations for its clinical performance in Cancer, Diabetes & Endocrinology, Gastroenterology & GI Surgery, Geriatrics, Gynecology, Nephrology, Neurology & Neurosurgery, Orthopedics, Pulmonology and Urology. It is also recognized nationally as a leader maternal/child health and offers a wide range of services in radiology, and medical and surgical specialties. For more information, go to www.lenoxhillhospital.org.
About SurgOne Foregut Institute
SurgOne Foregut Institute is a private clinic in south metro Denver, CO, and part of SurgOne PC. Dr. Reginald Bell is a surgeon specializing in esophageal and gastric disorders. Together with Katherine Freeman, N.P., who runs the foregut diagnostic lab, Dr. Bell has been involved in clinical research on Transoral Incisionless Fundoplication using the EsophyX device for over 5 years and published multiple papers on the procedure and outcomes. Most surgery is performed at Swedish Medical Center in south metro Denver, an acute care hospital of 368 beds that has dedicated resources to the treatment of esophageal and gastric disorders. www.sofisite.com/