2014-05-12 13:30:26 UTC

Participate in a New Medical Device Observational Research Registry for GERD

May 15, 2014

Visit www.gastro.org/STARreg to complete a site evaluation questionnaire and be considered for participation in a registry developed and managed by the AGA Center for GI Innovation and Technology to assess Laparoscopic Nissen Fundoplication (LNF) surgery versus Transoral Incisionless Fundoplication (TIF®).

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-Refulx Treatment Registry) will provide real-world data observing patient outcomes following traditional laproscopic 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, payors, purchasers, regulatory agencies, AGA and patients.

Please visit www.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.

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