Evaluation of NiTi Shape Memory End-to-End Compression Anastomosis Ring (CAR) for Compression Anastomosis in Anterior Resection

Phase 2

• Conditions: Colorectal Cancer

• Registration Number: NCT00468416
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Status Verified: 2007-05
• Study First Submitted: 2007-05-01
• Study First Submitted QC: 2007-05-01
• Study First Posted: 2007-05-02
• Last Update Submitted: 2007-05-03
• Last Update Posted: 2007-05-04
• Study Completion: 2008-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patient age over 18 years
• Patient scheduled for colorectal cancer surgery
• Patient is able to comprehend and sign the Informed Consent Form

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functioning anastomosis and no occurrence of adverse events related to device use	During hospitalization and one month post procedure

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel