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

Primary Purpose

Colorectal Cancer

Status

Unknown status

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

CAR™ 27

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring compression anastomosis, Colorectal cancer, Low anterior resection, Radiated to the pelvic area, Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

University Hospital, GasthuisbergRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAR™ 27

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01056796

First Posted

January 25, 2010

Last Updated

June 29, 2011

Sponsor

Niti Medical Technologies Ltd.

Collaborators

University Hospital, Gasthuisberg

1. Study Identification

Unique Protocol Identification Number

NCT01056796

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

May 2012 (Anticipated)

Study Completion Date

May 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Niti Medical Technologies Ltd.

Collaborators

University Hospital, Gasthuisberg

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CAR™ 27

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

CAR™ 27

Other Intervention Name(s)

Compression Anastomosis Ring

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Time Frame

Approx. 1 year

Secondary Outcome Measure Information:

Title

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

Time Frame

Approx. 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andre D'Hoore, Professor

Phone

+32 (16) 344265

andre.dhoore@uz.kuleuven.ac.be

First Name & Middle Initial & Last Name or Official Title & Degree

Yael Nir, MD

Phone

+972 (9) 8603000

Ext

3014

yael@nitisurgical.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andre D'Hoore, Professor

Organizational Affiliation

Gasthuisberg University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital, Gasthuisberg

City

Leuven

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andre D'Hoore, Professor

Phone

+32 (16) 344265

andre.dhoore@uz.kuleuven.ac.be

First Name & Middle Initial & Last Name & Degree

Guido Van Ermen, Mr.

Phone

+32 (16) 344265

guido.vanermen@uz.kuleuven.ac.be

First Name & Middle Initial & Last Name & Degree

Andre D'Hoore, Professor

12. IPD Sharing Statement

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

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