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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01056796
Recruitment Status : Unknown
Verified January 2010 by Niti Medical Technologies Ltd..
Recruitment status was:  Recruiting
First Posted : January 26, 2010
Last Update Posted : June 30, 2011
Sponsor:
Collaborator:
University Hospital, Gasthuisberg
Information provided by:
Niti Medical Technologies Ltd.

Tracking Information
First Submitted Date  ICMJE January 25, 2010
First Posted Date  ICMJE January 26, 2010
Last Update Posted Date June 30, 2011
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2010)
Evaluation of the creation of a functioning CAR™ 27 anastomosis in radiated patients [ Time Frame: Approx. 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27
Official Title  ICMJE Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Device: CAR™ 27
Creation of a low colorectal (side or pouch low rectal) compression anastomosis in previously radiated patients
Other Name: Compression Anastomosis Ring
Study Arms  ICMJE 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.
Intervention: Device: CAR™ 27
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 25, 2010)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2012
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01056796
Other Study ID Numbers  ICMJE Version: January 6, 2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Andre D'Hoore, Gasthuisberg University Hospital, Leuven, Belgium
Study Sponsor  ICMJE Niti Medical Technologies Ltd.
Collaborators  ICMJE University Hospital, Gasthuisberg
Investigators  ICMJE
Principal Investigator: Andre D'Hoore, Professor Gasthuisberg University Hospital
PRS Account Niti Medical Technologies Ltd.
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP