Status:
COMPLETED
A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses
Lead Sponsor:
Ethicon Endo-Surgery
Conditions:
Left-sided Colon Resection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This prospective clinical study will evaluate the intra-operative performance of the powered circular stapler used in left colectomy procedures in a post-market setting.
Detailed Description
Surgical staplers have been utilized in colorectal procedures since the early 20th century, with intraluminal staplers used to create the anastomosis since 1979. Successful utilization of these device...
Eligibility Criteria
Inclusion
- Scheduled for colectomy with left-sided anastomosis peformed with a circular stapler;
- Willing to give consent and comply with all study-related evaluations; and
- At least 18 years of age.
Exclusion
- Enrollment in a concurrent clinical study;
- Pregnancy;
- Physical or psychological condition which would impair study participation;
- Emergency surgery;
- ASA Class ≥ IV;
- The subject is judged unsuitable for study participation by the Investigator; or
- Unable or unwilling to provide follow-up information 8, Undergoing multiple intraoperative synchronous colon resections;
- 9\. Anastomosis not distal from splenic flexure of the colon 10. Anastomosis of the colon not attempted 11. Subjects with any intraoperative findings identified by the surgeon that would preclude attempting an anastomosis with a circular stapler.
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2020
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT03326895
Start Date
November 20 2017
End Date
January 15 2020
Last Update
January 11 2021
Active Locations (12)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294-0016
2
Colon & Rectal Clinic of Orlando
Orlando, Florida, United States, 32806
3
AdventHealth Tampa
Tampa, Florida, United States, 33613
4
Spectrum Health System
Grand Rapids, Michigan, United States, 49503