Medtronic Signia SDR Product Surveillance Registry

Completed

Conditions studied: Minimally Invasive Surgical Procedures, Surgical Procedures, Operative

In brief

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.

Key facts

Study ID

NCT05095935

Run by

Medtronic

People needed

430

Starts

2021-08-10

Expected to finish

2024-10-01

Last updated by the study team

2026-01-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
• Patient has, or is intended to receive or be treated with, an eligible Medtronic product
• Patient is consented within the enrollment window of the therapy received, as applicable

You may not qualify if…

• 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/device study that may confound the PSR results

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States
• Children's Hospital Colorado — Denver, Colorado, United States
• The George Washington University Hospital — Washington D.C., District of Columbia, United States
• Rush — Chicago, Illinois, United States
• Cooper Health System — Camden, New Jersey, United States
• NYU Langone Medical Center — New York, New York, United States
• New York Presbyterian Hospital - Colombia University Medical Center — New York, New York, United States
• UNC Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Health Systems — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• UPMC Falk Clinic — Pittsburgh, Pennsylvania, United States
• University of Texas - San Antonio — San Antonio, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Mary Washington Hopital — Fredericksburg, Virginia, United States

Full record on ClinicalTrials.gov

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