Purpose of this Study
We are doing this study to get more information about the safety and performance of the Signia® circular adapter and stapler (the study technology). This device is FDA-approved for use as a tool to connect or re-connect tissues after a surgery. We want to know how successful it is at promoting healing for people who have left sided colon, sigmoid, or rectal resections at Duke.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are scheduled for an elective colon/colorectal procedure that will be using the study technology
- Are not having the surgery as an emergency procedure, a revision/reoperation, or as part of multiple synchronous colon resections
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will be enrolled up until about 90 days after your planned procedure. During this time, we will ask you to answer some questionnaires at your follow-up visits after the surgery.
Locations
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A prospective, multicenter, single-arm, post market study to evaluate the safety and performance of the Signia™ Circular Stapler with Tri-Staple™ Technology in elective open or minimally invasive left-sided colon, sigmoid, and rectal resections (SECURE)
Principal Investigator
Katharine
Jackson
Protocol Number
PRO00117907
Phase
N/A
Enrollment Status
Pending Open to Enrollment