Registry to track and evaluate patient outcomes after procedures done with Apollo Endosurgery’s OverStitch™ Endoscopic Suturing System.

The American Gastroenterological Association (AGA) Center for GI Innovation and Technology announced that it will partner with Apollo Endosurgery, Inc. to establish a clinical research registry to track and evaluate patient outcomes after trans-oral endoscopic suturing procedures. These procedures allow physicians to place stitches in the upper or lower gastrointestinal tract using a flexible endoscope.

The Prospective Registry for Trans-Oral Suturing Applications (“Endoscopic Suturing Registry”) will collect real-world data related to the safety and effectiveness of procedures done with Apollo Endosurgery’s OverStitch™ Endoscopic Suturing System.

“Flexible endoscopic suturing is an important tool for the treatment of a number of gastroenterology disorders,” said Michael Kochman, MD, AGAF, director of the Center for Endoscopic Innovation, Research, and Training, University of Pennsylvania, and past chair, AGA Center for GI Innovation and Technology. “As these procedures become more routine in gastrointestinal and surgery practices across the country, the real-world data AGA will collect through the Endoscopic Suturing Registry will guide all stakeholders in making informed decisions around the continued adoption of these procedures in clinical practice.”

Through its registry initiative, AGA serves as a neutral, objective broker to establish and run registries that assess the safety and effectiveness of new technologies and therapies on patients. These data support the approval, coverage and adoption of devices and treatments that demonstrate promise and merit. This process allows innovations that will improve patient care to make it into physicians’ practices much faster than traditionally possible.

The data collected in the Endoscopic Suturing Registry will support informed decision making among physicians, purchasers and payors related to the approval, coverage and adoption of flexible endoscopic suturing devices. Most importantly, data on patient outcomes will lay the groundwork for shared decision making between patients and physicians about treatment options.

“As health care plans evaluate the benefits of flexible endoscopic suturing relative to traditional therapies, the Endoscopic Suturing Registry will be an important repository of highly credible clinical data,” said Todd Newton, CEO of Apollo Endosurgery. “Independent real-world data is an important consideration as health plans and payors determine coverage policies for procedures that depend on flexible endoscopic suturing.”

Jennifer Maranki, MD, director of endoscopy, Penn State Milton S. Hershey School of Medicine, and Brian Dunkin, MD, head of endoscopic surgery and medical director, Houston Methodist Institute for Technology, Innovation and Education, will serve as principal investigators for the Endoscopic Suturing Registry. The Registry will begin collecting patient data in early 2018.