Compression Anastomosis Using the CAR™ 27

This study has been completed.
Sponsor:
Collaborator:
novoGI
Information provided by:
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT00878241
First received: April 7, 2009
Last updated: February 23, 2011
Last verified: April 2009
  Purpose

Purpose:

Evaluation of the CAR™ 27 for the creation of compression anastomoses.

Indication:

Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colorectal resection.

Study Design:

Prospective, open labeled study.

Patient Population:

Male or female subjects 18 years of age or older who are scheduled for non emergency laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the discretion of the surgeon.

No. of Subjects:

15 patients estimated up to three months to enroll.

Duration of Treatment:

During the operation - creation of the anastomosis.

Duration of Follow-up:

Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3 months.

Endpoints:

To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse events related to the use of the CAR™ 27 device.


Condition Intervention
Colorectal Surgery
Device: Compression Anastomosis Ring: CAR™ 27

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc. [ Time Frame: 3-months ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: June 2008
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Compression Anastomosis Ring: CAR™ 27
    Creation of anastomosis in colorectal surgeries using CAR™ 27
    Other Name: CAR™ 27
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is over 18 years old.
  2. Patient is scheduled for a non-emergency procedure.
  3. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

Exclusion Criteria:

  1. Patient has an allergy to nickel.
  2. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease.
  3. Patient is participating in another clinical trial which may affect this study's outcomes.
  4. Patient has been taking regular steroid medication.
  5. Patient has contraindications to general anesthesia.
  6. Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878241

Locations
Israel
Bnai Zion Medical Center
Haifa, Israel, 3148
Sponsors and Collaborators
Bnai Zion Medical Center
novoGI
  More Information

No publications provided

Responsible Party: Dr. Ibrahim Matter, Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT00878241     History of Changes
Other Study ID Numbers: 08-CAR-07-IL-01
Study First Received: April 7, 2009
Last Updated: February 23, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Bnai Zion Medical Center:
Colon Anastomosis
Rectum Anastomosis
Intestine
Colorectal Surgery
Colorectal Anastomosis

ClinicalTrials.gov processed this record on August 20, 2014