Compression Anastomosis Using the CAR™ 27
Evaluation of the CAR™ 27 for the creation of compression anastomoses.
Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colorectal resection.
Prospective, open labeled study.
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.
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- 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 ]
|Study Start Date:||June 2008|
|Study Completion Date:||November 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Device: Compression Anastomosis Ring: CAR™ 27