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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Niti Medical Technologies Ltd..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Hospital, Gasthuisberg
Information provided by:
Niti Medical Technologies Ltd.
ClinicalTrials.gov Identifier:
NCT01056796
First received: January 25, 2010
Last updated: June 29, 2011
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Device: CAR™ 27
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27

Resource links provided by NLM:


Further study details as provided by Niti Medical Technologies Ltd.:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of the creation of a functioning CAR™ 27 anastomosis in radiated patients [ Time Frame: Approx. 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: January 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • CAR™ 27
  • Compression Anastomosis Ring

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056796

Contacts
Contact: Andre D'Hoore, Professor +32 (16) 344265 andre.dhoore@uz.kuleuven.ac.be
Contact: Yael Nir, MD +972 (9) 8603000 ext 3014 yael@nitisurgical.com

Locations
Belgium
University Hospital, Gasthuisberg Recruiting
Leuven, Belgium
Contact: Andre D'Hoore, Professor    +32 (16) 344265    andre.dhoore@uz.kuleuven.ac.be   
Contact: Guido Van Ermen, Mr.    +32 (16) 344265    guido.vanermen@uz.kuleuven.ac.be   
Principal Investigator: Andre D'Hoore, Professor         
Sponsors and Collaborators
Niti Medical Technologies Ltd.
University Hospital, Gasthuisberg
Investigators
Principal Investigator: Andre D'Hoore, Professor Gasthuisberg University Hospital
  More Information

No publications provided

Responsible Party: Prof. Andre D'Hoore, Gasthuisberg University Hospital, Leuven, Belgium
ClinicalTrials.gov Identifier: NCT01056796     History of Changes
Other Study ID Numbers: Version: January 6, 2010
Study First Received: January 25, 2010
Last Updated: June 29, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by Niti Medical Technologies Ltd.:
compression anastomosis
Colorectal cancer
Low anterior resection
Radiated to the pelvic area
Radiotherapy

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

ClinicalTrials.gov processed this record on October 23, 2014