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CompletedNCT00878241Updated Feb 24, 2011

Compression Anastomosis Using the CAR™ 27

An interventional study of Compression Anastomosis Ring: CAR™ 27 in Colorectal Surgery, sponsored by Bnai Zion Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-24.

Sponsored by Bnai Zion Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Surgery

Keywords

  • Colon Anastomosis
  • Rectum Anastomosis
  • Intestine
  • Colorectal Surgery
  • Colorectal Anastomosis
03

In context

Lead sponsor

Bnai Zion Medical Center is the lead sponsor of 102 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Interventions

  • DeviceCompression Anastomosis Ring: CAR™ 27

    Creation of anastomosis in colorectal surgeries using CAR™ 27

    Also known as: CAR™ 27

06

What researchers measure

Primary outcomes

  1. Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc.

    Time frame: 3-months

07

Study locations

1 site
  • Bnai Zion Medical Center
    Haifa, 3148, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00878241
Lead sponsor
Bnai Zion Medical Center
Collaborators
novoGI
First posted
Apr 8, 2009
Start date
Jun 2008
Primary completion
Jul 2009
Completion
Nov 2009
Last update
Feb 24, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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