Status:
UNKNOWN
Evaluation of NiTi Shape Memory End-to-End Compression Anastomosis Ring (CAR) for Compression Anastomosis in Anterior Resection
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborating Sponsors:
Rabin Medical Center
Kaplan Medical Center
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the NiTi CAR device in the creation of colorectal anastomosis
Eligibility Criteria
Inclusion
- Patient age over 18 years
- Patient scheduled for colorectal cancer surgery
- Patient is able to comprehend and sign the Informed Consent Form
Exclusion
- Patient has known allergy to nickel
- Patient with bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection
- Patients who are participating in another trial
- Patient on regular steroid medication
- Patients who are undergoing a stoma
- Patients with contraindications to general anesthesia
- Patient with preexisting sphincter problems or evidence of extensive local disease in the pelvis
- Patients after radiation
- Patients who refuse consent
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
End Date :
February 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00468416
Start Date
February 1 2007
End Date
February 1 2008
Last Update
May 4 2007
Active Locations (1)
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1
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel