Medtronic Signia SDR Product Surveillance Registry

Last updated: March 19, 2025
Sponsor: Medtronic
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

N/A observational registry

Clinical Study ID

NCT05095935
Surgical PSR
  • All Genders

Study Summary

The purpose of the registry is to confirm the safety and performance of the Signia™ Small Diameter Reload (SDR) when used in surgical procedures in a real-world setting in patients receiving surgery for indicated thoracic, abdominal, and pediatric applications, intraoperatively.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient or legally authorized representative (LAR) provides authorization and/orconsent per institution and geographical requirements

  • Patient has, or is intended to receive or be treated with, an eligible Medtronicproduct

  • Patient is consented within the enrollment window of the therapy received, asapplicable

Exclusion

Exclusion Criteria:

  • Patient who is, or is expected to be, inaccessible for follow-up

  • Patient is excluded by local law

  • Patient is currently enrolled in, or plans to enroll in, any concurrent drug/devicestudy that may confound the PSR results

Study Design

Total Participants: 430
Treatment Group(s): 1
Primary Treatment: N/A observational registry
Phase:
Study Start date:
August 10, 2021
Estimated Completion Date:
October 01, 2024

Connect with a study center

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Children's Hospital Colorado

    Denver, Colorado 80045
    United States

    Site Not Available

  • Rush

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Cooper Health System

    Camden, New Jersey 08103
    United States

    Site Not Available

  • UNC Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Duke University Health Systems

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • UPMC Falk Clinic

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • University of Texas - San Antonio

    San Antonio, Texas 78249
    United States

    Site Not Available

  • Mary Washington Hopital

    Fredericksburg, Virginia 22401
    United States

    Site Not Available

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