Compression Anastomosis Using the CAR™ 27
|ClinicalTrials.gov Identifier: NCT00878241|
Recruitment Status : Completed
First Posted : April 8, 2009
Last Update Posted : February 24, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Surgery||Device: Compression Anastomosis Ring: CAR™ 27||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||November 2009|
- Device: Compression Anastomosis Ring: CAR™ 27
Creation of anastomosis in colorectal surgeries using CAR™ 27Other Name: 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878241
|Bnai Zion Medical Center|
|Haifa, Israel, 3148|