Post-Market Medical Device Surveillance With a Novel mHealth Platform

Overview: The project will test the feasibility of using a mHealth app for post-market surveillance in patients (1) after sleeve gastrectomy and (2) after catheter-based atrial fibrillation ablation. Outcomes collected will include enrollment times, patient participation, dropout, completion of patient-reported outcome measure queries, and user satisfaction and burden. This study is enrolling 60 patients at Yale New Haven Hospital and Mayo Clinic.

Impact for NESTcc: The systematic process used to test and validate the mHealth app and assess its feasibility of use will provide insight and produce a framework for future use of mHealth apps in the post-market setting. Learnings will be extendable to pre-market evidence generation use-cases in the future.

Organization(s): Johnson & Johnson, U.S. Food and Drug Administration (FDA), Me2Health, Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI)

Principal Investigator(s): Joseph Ross, MD, MHS (Yale); Nilay Shah, PhD (Mayo)