Compression Anastomosis Using the CAR™ 27

NCT ID: NCT00867958

Last Updated: 2011-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-12-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Compression Anastomosis Ring: CAR™ 27

Creation of anastomosis in colorectal surgeries using CAR™ 27

Intervention Type: DEVICE

Other Intervention Names

CAR™ 27

Eligibility Criteria

Inclusion Criteria

1. Patient is over 18 years old.

2. Patient is scheduled for a non-emergency procedure.

3. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

Exclusion Criteria

1. Patient has an allergy to nickel.

2. 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.

3. Patient is participating in another clinical trial which may affect this study's outcomes.

4. Patient has been taking regular steroid medication.

5. Patient has contraindications to general anesthesia.

6. Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

novoGI

INDUSTRY

Sponsor Role: collaborator

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

HaEmek Medical Center, Israel

Principal Investigators

Yakov Khromov, Dr.

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

Locations

HaEmek Medical Center

Afula, , Israel

Countries

Israel

Other Identifiers

08-CAR-07-IL-01

Identifier Type: -

Identifier Source: org_study_id