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

Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

Approx. 1 year

Safety Issue:


Principal Investigator

Andre D'Hoore, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gasthuisberg University Hospital


Belgium: Institutional Review Board

Study ID:

Version: January 6, 2010



Start Date:

January 2010

Completion Date:

May 2012

Related Keywords:

  • Colorectal Cancer
  • compression anastomosis
  • Colorectal cancer
  • Low anterior resection
  • Radiated to the pelvic area
  • Radiotherapy
  • Colorectal Neoplasms