COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study

Completed · Phase 4

Conditions studied: Colorectal Surgery

In brief

The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers.

Key facts

Study ID

NCT01091155

Run by

novoGI

People needed

288

Starts

2010-03-01

Expected to finish

2011-07-01

Last updated by the study team

2013-10-25

Who can join

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

You may qualify if…

• Subject is ≥ 18 years old.
• BMI < 34.
• Subject is planned to undergo a non-emergency (i.e., elective) operation with the creation of an anastomosis using the ColonRing™.
• Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

You may not qualify if…

• Subject has a known allergy to nickel.
• Subject is planned to undergo an emergency procedure or has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel,carcinomatosis.
• Subject has participated in another clinical study which may affect this study's outcomes within the last 30 days.
• Subject's ASA (American Society of Anesthesiology) score 4 or 5.
• Subject has a concurrent or previous invasive pelvic malignancy.
• Subject has a systemic or incapacitating disease.
• Subject has extensive local disease in the pelvis.
• Subject requires more than one anastomosis during the surgery.
• Women who are known to be pregnant.

Where it is running

• UCI Medical Center — Irvine, California, United States
• University of Southern California Health Sciences Campus — Los Angeles, California, United States
• FPMG Center for Colon & Rectal Surgery — Orlando, Florida, United States
• Southern Regional Medical Center — Riverdale, Georgia, United States
• NorthShore University Health System — Evanston, Illinois, United States
• Lester E. Cox Medical Center — Springfield, Missouri, United States
• St. Louis University Hospital — St Louis, Missouri, United States
• KH Barmherzig Brueder — Vienna, Austria
• Ziekenhuis Oost Limburg — Genk, Belgium
• University Hospital Gasthuisberg — Leuven, Belgium
• Klinikum Neuperlach — Munich, Germany
• Bnai Zion Medical Center — Haifa, Israel
• Catharina Ziekenhuis — Eindhoven, Netherlands

Full record on ClinicalTrials.gov

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