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

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 2

Conditions: Colorectal Cancer

Treatments: Device: Compression Anastomosis Ring (CAR)

Study type: Interventional

Funder types: Other

Identifiers

NCT00468416

CLP-43-01-2

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of the NiTi CAR device in the creation of colorectal anastomosis

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)