Compression Anastomosis Using the Compression Anastomosis Ring (CAR™ 27) - Full Text View

Sponsors and Collaborators:	University Hospitals of Cleveland NiTi Surgical Solutions
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00859924

Purpose

The purpose of this research is to try to find out if a device called a Compression Anastomosis Ring (CAR™ 27) will make it easier for surgeons to reconnect the two ends of the intestine and reduce the risk of complications as part of an end-to-end anastomosis.

NiTi Surgical Solutions, Ltd is investigating a new device which compresses or pinches the two ends of the intestines together until natural scar tissue forms along the circumference of the reconnection site to heal it. The CAR™ 27 device is very similar to the stapling devices routinely used, and has been approved by the Food and Drug Administration (FDA) for the use of joining two ends of the intestine in humans in the United States.

Condition	Intervention
Inflammatory Bowel Diseases Peritonitis Colorectal Surgery	Device: CAR 27 Compression Anastomosis Ring

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Compression Anastomosis Using the CAR(TM) 27

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:

Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Parameters measured during the patient's hospitalization such as hospitalization time, time to flatus, time to bowel movements, time to toleration of liquids and fluids, use of narcotics and analgesics etc. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Quality of life measurements [ Time Frame: pre-op to 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	January 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CAR 27 Device use of CAR27 device in end-to-end anastomosis	Device: CAR 27 Compression Anastomosis Ring The CAR 27 is similar to a regular circular stapler. The anvil contains a durable plastic ring, designed to hold tissue firmly in place once joined to the base. The base of the device contains a ring that has shape-memory Nickel-titanium alloy springs inside. When the device is "fired" it holds the two ends of tissue together with circumferentially placed barbed points that penetrate from the metal ring through the tissue, holding it to the ring. The ring is released when the device is fired, creating a uniform compression around the ring.

Arms

Assigned Interventions

CAR 27 Device

use of CAR27 device in end-to-end anastomosis

Device: CAR 27 Compression Anastomosis Ring

The CAR 27 is similar to a regular circular stapler. The anvil contains a durable plastic ring, designed to hold tissue firmly in place once joined to the base. The base of the device contains a ring that has shape-memory Nickel-titanium alloy springs inside. When the device is "fired" it holds the two ends of tissue together with circumferentially placed barbed points that penetrate from the metal ring through the tissue, holding it to the ring. The ring is released when the device is fired, creating a uniform compression around the ring.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is over 18 years old.
Scheduled for a non-emergency procedure.
Patient 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 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 pre-existing sphincter problems or evidence of extensive local disease in the pelvis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859924

Contacts

Contact: Conor P. Delaney, MD, PhD	216-844-8087	conor.delaney@uhhospitals.org
Contact: Bridget Ermlich, RN, BSN	216-844-3602	bridget.ermlich@uhhospitals.org

Locations

United States, Ohio
University Hospitals Case Medical Center	Recruiting
Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

University Hospitals of Cleveland

NiTi Surgical Solutions

Investigators

Principal Investigator:

Conor P. Delaney, MD, PhD

University Hospitals Case Medical Center

More Information

No publications provided

Responsible Party:	University Hospitals Case Medical Center ( Conor Delaney, MD, PhD )
Study ID Numbers:	07-08-20
Study First Received:	March 9, 2009
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00859924 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:

Colon Resection
Rectum Resection
Intestine
Colorectal Surgery
Colorectal Resection

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Peritonitis
Peritoneal Diseases

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

Additional relevant MeSH terms:

Digestive System Diseases
Gastrointestinal Diseases
Peritonitis
Peritoneal Diseases

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on May 06, 2009