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

June 29, 2011 updated by: Niti Medical Technologies Ltd.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: CAR™ 27
Creation of a low colorectal (side or pouch low rectal) compression anastomosis in previously radiated patients
Other Names:
  • Compression Anastomosis Ring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Approx. 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Niti Medical Technologies Ltd.

Collaborators

University Hospital, Gasthuisberg

Investigators

  • Principal Investigator: Andre D'Hoore, Professor, Gasthuisberg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

January 25, 2010

First Posted (Estimate)

January 26, 2010

Study Record Updates

Last Update Posted (Estimate)

June 30, 2011

Last Update Submitted That Met QC Criteria

June 29, 2011

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version: January 6, 2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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