Signia Circular Stapler for Rectal Disease

(SECURE Trial)

Recruiting at 3 trial locations

Overseen By Yeshareg Yismaw

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic - MITG

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

137 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Katharine Louise Jackson, MD, FACS, MBBS, MA

Principal Investigator

Duke Raleigh Hospital

John Monson, MD, FACS

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for patients undergoing left-sided colon, sigmoid, or rectal resections. Specific conditions include intestinal diseases, colorectal anastomosis issues, and rectal cancer among others. Details on inclusion and exclusion criteria are not provided.

Inclusion Criteria

I am willing and able to give my consent to participate in this study.

I am 18 years old or older.

I am scheduled for a surgery on the left side of my colon using a specific stapling device.

Exclusion Criteria

Subject with ASA classification ≥ IV

I cannot or do not want to follow the study rules or schedule.

Subject is pregnant (as determined by standard site practices)

What Are the Treatments Tested in This Trial?

Interventions

• Signia Circular Stapler with Tri-Staple Technology

Trial Overview

The study evaluates the safety and performance of the Signia™ circular stapler with Tri-Staple™ Technology in surgeries for certain lower gastrointestinal tract conditions.

How Is the Trial Designed?

Group I: Left sided colon/colorectal procedure with creation of an anastomosis Experimental Treatment 1 Intervention

single arm study, no control arm

Who Is Running the Clinical Trial?

Medtronic - MITG

Lead Sponsor

Trials

265

Recruited

301,000+

Geoff Martha

Medtronic - MITG

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. John Doe

Medtronic - MITG

Chief Medical Officer since 2023

MD from Harvard Medical School