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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
Rabin Medical Center
Kaplan Medical Center
Information provided by:
Tel-Aviv Sourasky Medical Center Identifier:
First received: May 1, 2007
Last updated: May 3, 2007
Last verified: May 2007
The purpose of this study is to evaluate the safety and effectiveness of the NiTi CAR device in the creation of colorectal anastomosis

Condition Intervention Phase
Colorectal Cancer
Device: Compression Anastomosis Ring (CAR)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of NiTi Shape Memory End-to-End Compression Anastomosis Ring (CAR) for Compression Anastomosis in Anterior Resection

Resource links provided by NLM:

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Functioning anastomosis and no occurrence of adverse events related to device use [ Time Frame: During hospitalization and one month post procedure ]

Estimated Enrollment: 60
Study Start Date: February 2007
Estimated Study Completion Date: February 2008

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00468416

Contact: Hagit Tulchinsky, M.D. +972-3-6973315 ext 3315

Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Rabin Medical Center
Kaplan Medical Center
Principal Investigator: Hagit Tulchinsky, M.D. Tel-Aviv Sourasky Medical Center
  More Information Identifier: NCT00468416     History of Changes
Other Study ID Numbers: CLP-43-01-2
Study First Received: May 1, 2007
Last Updated: May 3, 2007

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases processed this record on April 28, 2017