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

Niti Medical Technologies

Status and phase: Unknown; Phase 2

Conditions: Colorectal Cancer

Treatments: Device: CAR™ 27

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01056796

Version: January 6, 2010

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

CAR™ 27

Experimental group

Description:

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.

Treatment:

Device: CAR™ 27