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

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

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: Compression Anastomosis Ring (CAR)

• Study Type: Interventional
• Enrollment: 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Tel Aviv Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functioning anastomosis and no occurrence of adverse events related to device use	During hospitalization and one month post procedure

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: Rabin Medical Center; Kaplan Medical Center
• Investigators: Principal Investigator: Hagit Tulchinsky, M.D., Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Study Completion: February 1, 2008

Study Registration Dates

• First Submitted: May 1, 2007
• First Submitted That Met QC Criteria: May 1, 2007
• First Posted (Estimate): May 2, 2007

Study Record Updates

• Last Update Posted (Estimate): May 4, 2007
• Last Update Submitted That Met QC Criteria: May 3, 2007
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CLP-43-01-2