Status:
COMPLETED
Compression Anastomosis Using the Compression Anastomosis Ring (CAR™ 27)
Lead Sponsor:
Aristotle University Of Thessaloniki
Collaborating Sponsors:
novoGI
Conditions:
Colorectal Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Purpose: Evaluation of the CAR™ 27 for the creation of compression anastomoses. Indication: Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colo...
Eligibility Criteria
Inclusion
- Patient is over 18 years old.
- Patient is scheduled for a non-emergency procedure.
- Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.
Exclusion
- Patient has an allergy to nickel.
- Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease.
- Patient is 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00880984
Start Date
June 1 2008
Last Update
January 7 2010
Active Locations (1)
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1
AHEPA University Hospital of Thessaloniki
Thessaloniki, Greece, 54636