Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27

Overview

The purpose of this study is: Evaluation of the safety and effectiveness of the Compression Anastomosis Ring (CAR™ 27) device for creation of circular, colorectal anastomoses in previously radiated patients.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2012

Interventions

  • Device: CAR™ 27
    • Creation of a low colorectal (side or pouch low rectal) compression anastomosis in previously radiated patients

Arms, Groups and Cohorts

  • Experimental: CAR™ 27
    • Any patient with a diagnosis of colorectal cancer that has been previously radiated to the pelvic area (6-8 weeks prior to surgery) and that is electively scheduled for an open or laparoscopic total mesorectal excision (TME) and low anterior resection surgery (< 10cm from the anal verge) which requires the creation of an anastomosis, will be offered participation in this study.

Clinical Trial Outcome Measures

Primary Measures

  • To evaluate for the occurrence of adverse events related to the use of the CAR™ 27 device, include anastomotic leak, bleeding, ring evacuation and strictures at 6 months.
    • Time Frame: Approx. 1 year

Secondary Measures

  • Evaluation of the creation of a functioning CAR™ 27 anastomosis in radiated patients
    • Time Frame: Approx. 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • Patient is ≥ 18 years old. – Patient is scheduled for a non-emergency TME and low anterior resection (< 10cm from the anal verge). – Patient has been radiated to the pelvic area 6-8 weeks prior to the study. – Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures. Exclusion Criteria:

  • Patient has known allergy to nickel. – Patient undergoing an emergency procedure or has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or inflammatory bowel disease. – Patients are participating in another clinical trial which may affect this study's outcomes. – Patient has been taking regular steroid medication. – Patient has contraindications to general anesthesia. – Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Niti Medical Technologies Ltd.
  • Collaborator
    • University Hospital, Gasthuisberg
  • Provider of Information About this Clinical Study
    • Prof. Andre D’Hoore, Gasthuisberg University Hospital, Leuven, Belgium
  • Overall Official(s)
    • Andre D’Hoore, Professor, Principal Investigator, Gasthuisberg University Hospital
  • Overall Contact(s)
    • Andre D’Hoore, Professor, +32 (16) 344265, andre.dhoore@uz.kuleuven.ac.be

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