The purpose of this study is:
Evaluation of the safety and effectiveness of the Compression Anastomosis Ring (CAR™ 27)
device for creation of circular, colorectal anastomoses in previously radiated patients.
Device: CAR™ 27
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Full eligibility criteria for NCT01056796
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Patient is ≥ 18 years old.
Patient is scheduled for a non-emergency TME and low anterior resection (< 10cm from the anal verge).
Patient has been radiated to the pelvic area 6-8 weeks prior to the study.
Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.
Patient has known allergy to nickel.
Patient undergoing an emergency procedure or has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or inflammatory bowel disease.
Patients are participating in another clinical trial which may affect this study's outcomes.
Patient has been taking regular steroid medication.
Patient has contraindications to general anesthesia.
Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.
All locations for NCT01056796
University Hospital, Gasthuisberg
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View full eligibility
Tris trial is registered with FDA with number: NCT01056796. The sponsor of the trial is Niti Medical Technologies Ltd. and it is looking for 10 volunteers for the current phase.
Official trial title: Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27
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