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Evaluation of NiTi Shape Memory End-to-End Compression Anastomosis Ring (CAR) for Compression Anastomosis in Anterior Resection
This study is currently recruiting participants.
Verified by Tel-Aviv Sourasky Medical Center, May 2007
First Received: May 1, 2007   Last Updated: May 3, 2007   History of Changes
Sponsors and Collaborators: Tel-Aviv Sourasky Medical Center
Rabin Medical Center
Kaplan Medical Center
Information provided by: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00468416
  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 II

MedlinePlus related topics: Cancer Colorectal Cancer Memory
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title: Evaluation of NiTi Shape Memory End-to-End Compression Anastomosis Ring (CAR) for Compression Anastomosis in Anterior Resection

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

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

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

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

ClinicalTrials.gov processed this record on May 06, 2009