Feasibility Study to Evaluate the use of mHealth as Data Source in Post-Market Surveillance

  • Overview

    This project will compare the quality and reliability of data acquired via the mHealth app (Hugo) to data acquired in an industry-owned post-market surveillance registry, Medtronic’s Product Surveillance Registry (PSR). This study is enrolling 30 patients from Yale New Haven hospital who are also registered in Medtronic’s PSR.

  • Impact for NESTcc

    The systematic process used to test and validate the mHealth app and validate 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.

  • Organizations

    Medtronic, Yale University, Me2Health

  • Principal Investigators

    Rachael Lampert, MD, Yale

Follow us @NESTccMedTech

NESTcc's Test-Case study protocol on synthetic mid-urethral slings for stress urinary incontinence in women is open for public comment through June 12. More: bit.ly/2RM654T pic.twitter.com/fk4ore1Kmg 1 day ago

NESTcc is requesting public comments on the study protocol of our Test-Case focused on synthetic mid-urethral slings for stress urinary incontinence in women. The comment period is open until June 12. More: bit.ly/2RM654T pic.twitter.com/5owFLFq1Fl 1 week ago

National Evaluation System for health Technology Coordinating Center (NESTcc)
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