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New surgical stapler proves safe in 430 Real-World procedures

NCT ID NCT05095935

Knowledge-focused Sponsor: Medtronic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This registry tracked 430 patients who received surgery with the Signia Small Diameter Reload stapler for chest, belly, or pediatric operations. The goal was to confirm the device works safely in everyday hospital use. Researchers measured how often doctors needed extra steps to stop bleeding or leaks during surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

430 people

The number who actually took part.

Started

Aug 2021

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients undergoing surgical procedures during which the Signia Small Diameter Reload is being used for transection of the arteries and veins meeting the cohort criteria.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 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/device study that may confound the PSR results

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Minimally invasive surgical procedures Surgical procedures, operative

Contacts and locations

Locations

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Children's Hospital Colorado

    Denver, Colorado, 80045, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cooper Health System

    Camden, New Jersey, 08103, United States

  • Duke University Health Systems

    Durham, North Carolina, 27705, United States

  • Mary Washington Hopital

    Fredericksburg, Virginia, 22401, United States

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • New York Presbyterian Hospital - Colombia University Medical Center

    New York, New York, 10032, United States

  • Rush

    Chicago, Illinois, 60612, United States

  • The George Washington University Hospital

    Washington D.C., District of Columbia, 20037, United States

  • UNC Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • UPMC Falk Clinic

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Texas - San Antonio

    San Antonio, Texas, 78249, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

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