NCT07351071

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Dec 2025

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Dec 2025Feb 2027

Study Start

First participant enrolled

December 30, 2025

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

January 16, 2026

Last Update Submit

June 11, 2026

Conditions

Colorectal AnastomosisLeft-sided Colon ResectionDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesAnastomotic LeakAnastomotic ComplicationRectal DiseasesPostoperative ComplicationsAnastomotic Leaks

Keywords

Colorectal AnastomosisLeft-sided Colon ResectionCircular staplerAnastomotic LeakRectal cancerLow anterior resectionPowered stapler

Outcome Measures

Primary Outcomes (1)

  • Incidence of anastomotic leak

    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 impact the primary endpoint analysis.

    within 30 days, +/- 14 days

Secondary Outcomes (7)

  • Incidence of anastomotic leaks

    within 90 days, +/- 14 days

  • Clinical significance of anastomotic leaks

    within 90 days, +/- 14 days

  • Incidence of a Signia™ circular stapler and accessory components device deficiency (DD)

    Day 0 (day of surgery)

  • Incidence of anastomotic bleeding

    within 30 and 90 days, +/- 14 days

  • Incidence of device-related adverse events

    within 90 days, +/- 14 days

  • +2 more secondary outcomes

Other Outcomes (4)

  • Surgeon satisfaction

    Day 0 (day of surgery)

  • Incidence of serious device-related adverse events

    within 90 days, +/- 14 days

  • Clavien-Dindo classification of surgical complications

    within 90 days, +/- 14 days

  • +1 more other outcomes

Study Arms (1)

Left sided colon/colorectal procedure with creation of an anastomosis

EXPERIMENTAL

single arm study, no control arm

Device: Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)

Interventions

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

Signia™ Circular Stapling system used for the creation of an anastomosis

Left sided colon/colorectal procedure with creation of an anastomosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is competent and willing to provide documented informed consent to participate in this clinical study
  • Subject is intended to undergo an elective left sided colon/colorectal procedure where a creation of an anastomosis will be completed with the Signia™ circular stapler
  • Subject is ≥ 18 years of age at time of consent

You may not qualify if:

  • Subject is unable or unwilling to comply with the study requirements or follow-up schedule
  • Subject with ASA classification ≥ IV
  • Subject is pregnant (as determined by standard site practices)
  • The procedure is an emergency procedure
  • The procedure is a revision/reoperation for the same indication
  • The subject has a documented confounding medical condition which in the opinion of the investigator, will not be appropriate for the study, or the subject has an estimated life expectancy of less than 6 months
  • Subject has participated or plans to participate in an investigational drug or device research study that would interfere with the results of this study
  • Subject will undergo multiple synchronous colon resections
  • Subject with a bleeding disorder or is undergoing anticoagulant treatment that has not been reversed (anticoagulant prophylaxis prescribed as part of the surgical protocol is allowed)
  • Subject has undergone chemotherapy or received biologics within 6 weeks prior to the day of the procedure
  • Subject has history of chronic corticosteroid use (used greater than 3 months within a year prior to the index procedure)
  • Subject has chronic immunosuppression therapy (used greater than 3 months within a year prior to the index procedure)
  • Any subject undergoing an ileal-anal pouch anastomosis surgery
  • Anastomosis not attempted with the Signia™ circular stapler
  • Any subject for which the device is intended to be used outside the instructions for use (IFU)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

The University of South Florida

Tampa, Florida, 33620, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Mayo Clinic

Rochester, Minnesota, 55902, United States

NOT YET RECRUITING

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

SSM Health St. Mary's Hospital - Madison

Madison, Wisconsin, 53715, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Anastomotic LeakDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPostoperative ComplicationsRectal Neoplasms

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Katharine Louise Jackson, MD, FACS, MBBS, MA

    Duke Raleigh Hospital

    PRINCIPAL INVESTIGATOR

  • John Monson, MD, FACS

    Northwell Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeshareg Yismaw

CONTACT

+7635050079yeshareg.g.yismaw@medtronic.com

Study Mailbox

CONTACT

rs.securestudy@medtronic.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 20, 2026

Study Start

December 30, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(9)