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

Phase 2

• Conditions: Colorectal Cancer
• Interventions: Device: CAR™ 27

• 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

Arm && Interventions

Group	Intervention	Description
CAR™ 27	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.

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