Compression Anastomosis Using the CAR™ 27

Colorectal Surgery Clinical Trial

Official title: Compression Anastomosis Using the CAR™ 27

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Surgery

• NCT number: NCT00867958
• Study type: Interventional
• Source: HaEmek Medical Center, Israel
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Completion date: December 2009