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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00468416
• Other study ID #: CLP-43-01-2
• Status: Recruiting
• Phase: Phase 2
• First received: May 1, 2007
• Last updated: May 3, 2007
• Start date: February 2007
• Est. completion date: February 2008

Study information

• Verified date: May 2007
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Hagit Tulchinsky, M.D.
• Phone: +972-3-6973315
• Email: hagitt[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Device:
• Compression Anastomosis Ring (CAR)

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (3)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Kaplan Medical Center, Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functioning anastomosis and no occurrence of adverse events related to device use		During hospitalization and one month post procedure