NCT00867958

Compression Anastomosis Using the CAR™ 27

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Surgery

Interventions

Type	Name	Description
DEVICE	Compression Anastomosis Ring: CAR™ 27	Creation of anastomosis in colorectal surgeries using CAR™ 27

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-02-01
• Completion: 2009-12-01
• First posted: 2009-03-24
• Last updated: 2011-02-23

Locations

1 site across 1 country: Israel