A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses

Completed · Not applicable

Conditions studied: Left-sided Colon Resection

In brief

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.

Key facts

Study ID

NCT03326895

Run by

Ethicon Endo-Surgery

People needed

168

Starts

2017-11-20

Expected to finish

2020-01-15

Last updated by the study team

2021-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;
• 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.

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• Colon & Rectal Clinic of Orlando — Orlando, Florida, United States
• AdventHealth Tampa — Tampa, Florida, United States
• Spectrum Health System — Grand Rapids, Michigan, United States
• Mt. Sinai Hospital / Mt. Sinai School of Medicine — New York, New York, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Ziekenhuis Oost-Limburg — Genk, Belgium
• Schon Klinik Neustadt — Neustadt, Germany
• Hospital Universitario Virgen Rocio — Seville, Spain
• University Hospitals Birmingham NHS — Birmingham, United Kingdom
• St Jame's University Hospital — Leeds, United Kingdom
• St. Mary's Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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