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Compression Anastomosis Using the CAR™ 27

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ClinicalTrials.gov Identifier: NCT00878241
Recruitment Status : Completed
First Posted : April 8, 2009
Last Update Posted : February 24, 2011
Sponsor:
Collaborator:
novoGI
Information provided by:
Bnai Zion Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Colorectal Surgery Device: Compression Anastomosis Ring: CAR™ 27 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : November 2009

Intervention Details:
    Device: Compression Anastomosis Ring: CAR™ 27
    Creation of anastomosis in colorectal surgeries using CAR™ 27
    Other Name: CAR™ 27


Primary Outcome Measures :
  1. Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc. [ Time Frame: 3-months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878241


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

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
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: February 24, 2011
Last Verified: April 2009

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