Compression Anastomosis Using the Compression Anastomosis Ring (CAR™ 27)
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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 |
| Official Title: | Compression Anastomosis Using the CAR™ 27 |
- 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 ]
| Estimated Enrollment: | 15 |
| Study Start Date: | June 2008 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
-
Device: Compression Anastomosis Ring: CAR™ 27
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient is over 18 years old.
- Patient is scheduled for a non-emergency procedure.
- Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.
Exclusion Criteria:
- Patient has an allergy to nickel.
- 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.
- Patient is participating in another clinical trial which may affect this study's outcomes.
- Patient has been taking regular steroid medication.
- Patient has contraindications to general anesthesia.
- Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.
Contacts and Locations| Greece | |
| AHEPA University Hospital of Thessaloniki | |
| Thessaloniki, Greece, 54636 | |
| Principal Investigator: | Spiros Papavramidis, Prof. | AHEPA University Hospital of Thessaloniki |
More Information
No publications provided
| Responsible Party: | Prof. Spyros Papavramidis, AHEPA university Hospital of Thessaloniki |
| ClinicalTrials.gov Identifier: | NCT00880984 History of Changes |
| Other Study ID Numbers: | 08-CAR-07-Gr-01 |
| Study First Received: | April 13, 2009 |
| Last Updated: | January 6, 2010 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Aristotle University Of Thessaloniki:
|
Colon Anastomosis Rectum Anastomosis Intestine Colorectal Surgery Colorectal Anastomosis |
ClinicalTrials.gov processed this record on May 16, 2013