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

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ClinicalTrials.gov Identifier: NCT00468416
Recruitment Status : Unknown
Verified May 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : May 2, 2007
Last Update Posted : May 4, 2007
Sponsor:
Collaborators:
Rabin Medical Center
Kaplan Medical Center
Information provided by:
Tel-Aviv Sourasky Medical Center

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Device: Compression Anastomosis Ring (CAR) Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2007
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
U.S. FDA Resources




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00468416     History of Changes
Other Study ID Numbers: CLP-43-01-2
First Posted: May 2, 2007    Key Record Dates
Last Update Posted: May 4, 2007
Last Verified: May 2007

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