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AGA, Apollo Endosurgery launch endoscopic suturing registry
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The AGA announced it has launched a clinical registry in partnership with Apollo Endosurgery to track outcomes of trans-oral endoscopic suturing procedures performed with the company’s OverStitch system.
The Prospective Registry for Trans-Oral Suturing Applications will collect and evaluate real-world safety and effectiveness data on these “less invasive” procedures, during which a flexible endoscope is used to place full-thickness sutures in the GI tract, according to an AGA press release. The association said these data will support informed decision-making about these devices among patients, physicians, purchasers and payors.
“Flexible endoscopic suturing is an important tool for the treatment of a number of gastroenterology disorders,” Michael Kochman, MD, AGAF, director of the Center for Endoscopic Innovation, Research, and Training at University of Pennsylvania, and former chair of the AGA Center for GI Innovation and Technology, said in the press release. “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.”
The registry will start collecting patient data early next year, and will be led by principal investigators Jennifer Maranki, MD, director of endoscopy at Penn State Milton S. Hershey School of Medicine, and Brian Dunkin, MD, head of endoscopic surgery and medical director at Houston Methodist Institute for Technology, Innovation and Education.
“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,” Todd Newton, CEO of Apollo Endosurgery, said in the press release. “Independent real-world data is an important consideration as health plans and payors determine coverage policies for procedures that depend on flexible endoscopic suturing.”
As with other registries launched by the association, AGA said it will serve as “a neutral, objective broker” in its establishment and operations. The goal of the AGA’s registry initiative is to accelerate access to innovative therapies that show “promise and merit.”
Disclosures: Newton is employed by Apollo Endosurgery.