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

NCT01056796 | Unknown Phase 2

• 1 other identifier: Version: January 6, 2010
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of the creation of a functioning CAR™ 27 anastomosis in radiated patients

  Approx. 1 year

Study Arms (1)

CAR™ 27

EXPERIMENTAL

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.

Device: CAR™ 27

Interventions

CAR™ 27 DEVICE

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

Also known as: Compression Anastomosis Ring

CAR™ 27

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Niti Medical Technologies Ltd.: lead
• University Hospital, Gasthuisberg: collaborator

Study Sites (1)

University Hospital, Gasthuisberg

Leuven, Belgium

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Andre D'Hoore, Professor

  Gasthuisberg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andre D'Hoore, Professor

CONTACT

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

Yael Nir, MD

CONTACT

+972 (9) 8603000; yael@nitisurgical.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 26, 2010
• Study Start: January 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 30, 2011

Record last verified: 2010-01

Locations

BE (1)