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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 because the information has not been verified recently.
Verified May 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Rabin Medical Center
Kaplan Medical Center
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00468416
First received: May 1, 2007
Last updated: May 3, 2007
Last verified: May 2007
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468416

Contacts
Contact: Hagit Tulchinsky, M.D. +972-3-6973315 ext 3315 hagitt@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Rabin Medical Center
Kaplan Medical Center
Investigators
Principal Investigator: Hagit Tulchinsky, M.D. Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00468416     History of Changes
Other Study ID Numbers: CLP-43-01-2
Study First Received: May 1, 2007
Last Updated: May 3, 2007
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013