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

Phase 2

• Conditions: Colorectal Cancer

• Registration Number: NCT01056796
• Lead Sponsor: Niti Medical Technologies Ltd.

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 available

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Last Update Submitted: 2011-06-29
• Last Update Posted: 2011-06-30
• Primary Completion: 2012-05
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Evaluation of the creation of a functioning CAR™ 27 anastomosis in radiated patients	Approx. 1 year

Trial Locations

Locations (1)

University Hospital, Gasthuisberg; 🇧🇪 Leuven, Belgium