San Cesario, Italy

  • A Retrospective Assessment of OviTex PRS (OviTex)

    This study is organized as a retrospective-prospective, observational, multi-center study. The treatment group involved in the study received OviTex PRS during implant-based breast reconstruction. The reconstruction procedure was an immediate or two-stage unilateral or bilateral implant in either the sub-pectoral or pre-pectoral position. Results from this study are aimed to demonstrate an acceptable safety profile and to inform the study design and effectiveness endpoints of a future prospective study.

    Phase

    N/A

    Span

    171 weeks

    Sponsor

    Tela Bio Inc

    Naples, Florida

    Recruiting

  • MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study

    In this study the treatment group will include all patients receiving MILD, and the control group will include all patients receiving IPD for the treatment of LSS during the enrollment period. Reoperation and harms data will be studied for the MILD and IPD procedures for a 24-month follow-up period after the index procedure using Medicare claims data. This study is exempt from IRB oversight (Department of Health and Human Services regulations 45 CFR 46) and does not require prior enrollment nor patient consent. The inclusion of the study's NCT number on MILD Medicare claims is required and results in enrollment.

    Phase

    N/A

    Span

    512 weeks

    Sponsor

    Vertos Medical, Inc.

    Naples, Florida

    Recruiting

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