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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01056796
• Other study ID #: Version: January 6, 2010
• Status: Recruiting
• Phase: Phase 2
• First received: January 25, 2010
• Last updated: June 29, 2011
• Start date: January 2010
• Est. completion date: May 2012

Study information

• Verified date: January 2010
• Source: Niti Medical Technologies Ltd.
• Contact: Andre D'Hoore, Professor
• Phone: +32 (16) 344265
• Email: andre.dhoore[@]uz.kuleuven.ac.be
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hospital, Gasthuisberg	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Niti Medical Technologies Ltd.	University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Evaluation of the creation of a functioning CAR™ 27 anastomosis in radiated patients		Approx. 1 year	Yes