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

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

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMedtronic - MITG

About 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

137 Participants

are divided into 1 treatment group

Locations

Connecticut

Yale University06520, New Haven United States

Florida

The University of South Florida33620, Tampa United States

Massachusetts

Massachusetts General Hospital02114, Boston United States

Minnesota

Mayo Clinic55902, Rochester United States

Sponsors and collaborators

Medtronic - MITG

Lead sponsor

Source ClinicalTrials.gov