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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01056796

Enrollment

Registered

2010-01-26

Start date

2010-01-31

Completion date

2012-05-31

Last updated

2011-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

compression anastomosis, Colorectal cancer, Low anterior resection, Radiated to the pelvic area, Radiotherapy

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.

Interventions

DEVICECAR™ 27

Creation of a low colorectal (side or pouch low rectal) compression anastomosis in previously radiated patients

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Belgium

Contacts

Primary ContactAndre D'Hoore, Professor

andre.dhoore@uz.kuleuven.ac.be+32 (16) 344265

Backup ContactYael Nir, MD

yael@nitisurgical.com+972 (9) 8603000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026