Compression Anastomosis Using the CAR™ 27

Colorectal Surgery Clinical Trial

Official title:

Compression Anastomosis Using the CAR™ 27

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00867958
• Other study ID #: 08-CAR-07-IL-01
• Status: Completed
• Phase: N/A
• First received: March 22, 2009
• Last updated: February 20, 2011
• Start date: September 2008
• Est. completion date: December 2009

Study information

• Verified date: May 2009
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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

Intervention

Device:
• Compression Anastomosis Ring: CAR™ 27
Creation of anastomosis in colorectal surgeries using CAR™ 27

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	Afula

Sponsors (2)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel	novoGI

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc.		3-mo	No