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

May 3, 2007 updated by: Tel-Aviv Sourasky Medical Center
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

Intervention / Treatment

Study Type

Interventional

Enrollment

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: During hospitalization and one month post procedure
During hospitalization and one month post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • CLP-43-01-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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