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

Recruiting N/A Interventional Study
Colorectal Anastomosis Left-sided Colon Resection Anastomotic Leak Anastomotic Complication Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Postoperative Complications Anastomotic Leaks
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
137 (estimated)
Sponsor
Medtronic - MITG · Industry
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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.

Trial Locations
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Eligibility Criteria
Preoperative Inclusion Criteria: 1. Subject is competent and willing to provide documented informed consent to participate in this clinical study 2. Subject is intended to undergo an elective left sided colon/colorectal procedure where a creation of an anastomosis will be completed with the Signia™…
Contacts

Yeshareg Yismaw

+7635050079

yeshareg.g.yismaw@medtronic.com

CONTACT

Study Mailbox

rs.securestudy@medtronic.com

CONTACT