Participate in new GERD device registry
Are you interested in participating in medical device observational research registries?
There is an opportunity to be considered as one of only 20 sites designated to participate in a registry developed and managed by the AGA Center for GI Innovation and Technology on behalf of EndoGastric Solutions® comparing surgery to incisionless procedures for treating gastroesophageal reflux disease (GERD).
The "STAR Registry" [Laparoscopic Nissen Fundoplication (LNF) Surgery versus Transoral Incisionless Fundoplication (TIF®): Anti-Reflux Treatment Registry] will provide real-world data observing patient outcomes following traditional laparoscopic surgery and TIF with EsophyX® device.
As a neutral, objective broker, AGA is establishing registries to help companies gather the data needed by payors, purchasers, risk-bearing organizations, and regulatory agencies to support the approval, coverage, reimbursement, and adoption of new technologies, therapies, and procedures.
Registries can provide data to allow stakeholders to evaluate efficacy of a device and document safety and durability.
Strict methodology and structures must be applied to an observational registry to balance the needs of health care professionals, companies, payers, purchasers, regulatory agencies, AGA, and patients.
Please visit gastro.org/STARreg to complete the site evaluation questionnaire to be considered to participate in the STAR Registry. If you have any questions, please contact Leah White, MPH, CCRP, director of registry development and integrity, at lwhite@gastro.org or 301-941-2615.