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Sponsors and Collaborators: |
Aristotle University Of Thessaloniki NiTi Surgical Solutions |
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Information provided by: | Aristotle University Of Thessaloniki |
ClinicalTrials.gov Identifier: | NCT00880984 |
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 |
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Colorectal Surgery |
Device: Compression Anastomosis Ring: CAR™ 27 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Compression Anastomosis Using the CAR™ 27 |
Estimated Enrollment: | 15 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Greece | |
AHEPA University Hospital of Thessaloniki | |
Thessaloniki, Greece, 54636 |
Principal Investigator: | Spiros Papavramidis, Prof. | AHEPA University Hospital of Thessaloniki |
Responsible Party: | AHEPA university Hospital of Thessaloniki ( Prof. Spyros Papavramidis ) |
Study ID Numbers: | 08-CAR-07-Gr-01 |
Study First Received: | April 13, 2009 |
Last Updated: | July 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00880984 History of Changes |
Health Authority: | Israel: Ministry of Health |
Colon Anastomosis Rectum Anastomosis Intestine Colorectal Surgery Colorectal Anastomosis |