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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00867958
Other study ID # 08-CAR-07-IL-01
Secondary ID
Status Completed
Phase N/A
First received March 22, 2009
Last updated February 20, 2011
Start date September 2008
Est. completion date December 2009

Study information

Verified date May 2009
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Device:
Compression Anastomosis Ring: CAR™ 27
Creation of anastomosis in colorectal surgeries using CAR™ 27

Locations

Country Name City State
Israel HaEmek Medical Center Afula

Sponsors (2)

Lead Sponsor Collaborator
HaEmek Medical Center, Israel novoGI

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc. 3-mo No
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