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NCT07351071 · ClinicalTrials.gov registry record · NA

Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections

A NA study of Postoperative Complications and Gastrointestinal Diseases, sponsored by Medtronic - MITG.

Recruiting
Registry status
NA
Development phase
137
Enrollment target
8
Study locations

NCT07351071: Recruiting NA study of Postoperative Complications and Gastrointestinal Diseases, sponsored by Medtronic - MITG.

NCT07351071 is a NA study of Postoperative Complications and Gastrointestinal Diseases that is actively recruiting participants, run by Medtronic - MITG. The registered enrollment target is 137 participants, below the 555-participant average among 20 other Postoperative Complications trials with a reported enrollment target (75% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07351071, a NA study of Postoperative Complications and Gastrointestinal Diseases, is actively recruiting participants, sponsored by Medtronic - MITG.

RECRUITING
Registry status
NA
Development phase
137 participants
Enrollment target
8
Study locations

Study Summary

The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in patients undergoing left sided colon, sigmoid, or rectal resections in a post market setting.

Primary Outcome

Incidence of anastomotic leak following the use of the Signia™ circular stapler used in subjects undergoing left sided colon, sigmoid, or rectal resections. Diagnosis will be confirmed postoperatively by computed tomography (CT) imaging (with or without a contrast agent), or postoperatively via direct verification during re-operation. Anastomotic leakage confirmed to have occurred at a staple line other than the colon/colorectal anastomosis created with the Signia™ circular stapler will not impa

Conditions Studied

Postoperative Complications Gastrointestinal Diseases Colonic Diseases Digestive System Diseases Intestinal Diseases Anastomotic Leak Rectal Diseases Colorectal Anastomosis Left-sided Colon Resection Anastomotic Complication

Interventions

  • DEVICE Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)

Study Locations (8)

Connecticut

  • Yale University - New Haven

Florida

  • The University of South Florida - Tampa

Massachusetts

  • Massachusetts General Hospital - Boston

North Carolina

  • Duke University - Durham

Ohio

  • The Ohio State University Wexner Medical Center - Columbus

Pennsylvania

  • Lankenau Institute for Medical Research - Wynnewood

Texas

  • University of Texas Health Science Center at Houston - Houston

Wisconsin

  • SSM Health St. Mary's Hospital - Madison - Madison

Trial Details

FieldValue
Enrollment Target 137 participants
Start Date 2025-12-30
Est. Completion 2027-02-28
Phase NA
Medtronic - MITG

119 total trials

What NCT07351071 shows while recruiting

NCT07351071 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, below the 555-participant average among 20 other Postoperative Complications trials with a reported enrollment target (75% lower).

The record links to 10 conditions, with Postoperative Complications appearing as the primary indexed condition, and to 1 intervention - of which Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system) is the first listed.

NCT07351071 lists 8 locations in 8 states (Connecticut, Florida, Massachusetts).

Frequently Asked Questions

What is clinical trial NCT07351071 about?

NCT07351071 is a clinical study titled "Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections". The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in patients undergoing left sided colon, sigmoid, or rectal resections in a post...

What is the current status of trial NCT07351071?

This trial is currently recruiting. It is a NA study. The enrollment target is 137 participants. The study started on 2025-12-30. Estimated completion is 2027-02-28.

What conditions does trial NCT07351071 study?

This clinical trial studies the following conditions: Postoperative Complications, Gastrointestinal Diseases, Colonic Diseases, Digestive System Diseases, Intestinal Diseases.

What interventions are being tested in trial NCT07351071?

The interventions under investigation include: Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system) (DEVICE).

Who is sponsoring clinical trial NCT07351071?

This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07351071 being conducted?

This trial has 8 study locations across Connecticut, Florida, Massachusetts, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Postoperative Complications

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07351071's enrollment target sits among peer trials

137 10th of 20 higher than 11 of 20 other Postoperative Complications trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Postoperative Complications trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07351071

Source: ClinicalTrials.gov NCT07351071, the US trial registry maintained by the National Library of Medicine. NCT07351071 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.