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

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: Colorectal Cancer
• Intervention / Treatment: Device: CAR™ 27

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • Recruiting
    • University Hospital, Gasthuisberg
    • Contact: Andre D'Hoore, Professor; Phone Number: +32 (16) 344265; Email: andre.dhoore@uz.kuleuven.ac.be
    • Contact: Guido Van Ermen, Mr.; Phone Number: +32 (16) 344265; Email: guido.vanermen@uz.kuleuven.ac.be
    • Principal Investigator: Andre D'Hoore, Professor

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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.	Approx. 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Niti Medical Technologies Ltd.
• Collaborators: University Hospital, Gasthuisberg
• Investigators: Principal Investigator: Andre D'Hoore, Professor, Gasthuisberg University Hospital

Study record dates

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: Colorectal cancer; Radiotherapy; Low anterior resection; compression anastomosis; Radiated to the pelvic area
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Version: January 6, 2010