New stapler aims to reduce leaks after colon surgery

NCT ID NCT07351071

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

Summary

This study is testing a new surgical stapler, called the Signia circular stapler, in people having left-sided colon, sigmoid, or rectal surgery. The goal is to see if it lowers the chance of a leak where the colon is reconnected. About 137 adults will take part, and the main focus is safety and how well the stapler works.

What this could mean

Our plain-language read of the trial. This is informational only โ€” not medical advice or a prediction.

Active substance
Signia circular stapler (a surgical device used to reconnect the colon after resection)
What this could lead to
If successful, this could show that the Signia stapler is safe and effective for left-sided colon surgery, potentially reducing the risk of anastomotic leaks.
What could go wrong
This is a single-arm, post-market study with no comparison group, so results may not prove superiority over other staplers. The main risk is still anastomotic leakage, which can be serious.

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak colonic disorder Digestive System Diseases digestive system disorder intestinal disorder Postoperative Complications rectal disorder rectal neoplasm

As listed by the trial registrant

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

Contacts and locations

Locations

  • Duke University

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Lankenau Institute for Medical Research

    RECRUITING

    Wynnewood, Pennsylvania, 19096, United States

  • Massachusetts General Hospital

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    NOT_YET_RECRUITING

    Rochester, Minnesota, 55902, United States

  • SSM Health St. Mary's Hospital - Madison

    NOT_YET_RECRUITING

    Madison, Wisconsin, 53715, United States

  • The Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of South Florida

    RECRUITING

    Tampa, Florida, 33620, United States

  • University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States

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