Compression Anastomosis Using the CAR™ 27

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.

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Key information

Conditions

Colorectal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HaEmek Medical Center

Afula, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient is over 18 years old.
Patient is scheduled for a non-emergency procedure.
Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

Exclusion criteria

Patient has an allergy to nickel.
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.
Patient is participating in another clinical trial which may affect this study's outcomes.
Patient has been taking regular steroid medication.
Patient has contraindications to general anesthesia.
Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.

Treatment and study plan

Compression Anastomosis Ring: CAR™ 27

Device

Creation of anastomosis in colorectal surgeries using CAR™ 27

Other names: CAR™ 27

Primary outcomes

Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc.

Time frame: 3-mo

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Collaborators

novoGI

Registry information

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Mar 24, 2009
Registry last updated: Feb 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed