Compression Anastomosis Using the Compression Anastomosis Ring (CAR™ 27)

NCT00880984 | Completed

• 1 other identifier: 08-CAR-07-Gr-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Colon Anastomosis; Rectum Anastomosis; Intestine; Colorectal Surgery; Colorectal Anastomosis

Outcome Measures

Primary Outcomes (1)

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

  3-months

Interventions

Compression Anastomosis Ring: CAR™ 27 DEVICE

Creation of anastomosis in colorectal surgeries using CAR™ 27

Also known as: CAR™ 27

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• novoGI: collaborator

Study Sites (1)

AHEPA University Hospital of Thessaloniki

Thessaloniki, 54636, Greece

Location

Study Officials

• Spiros Papavramidis, Prof.

  AHEPA University Hospital of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 13, 2009
• First Posted: April 14, 2009
• Study Start: June 1, 2008
• Primary Completion: September 1, 2009
• Last Updated: January 7, 2010

Record last verified: 2009-07

Locations

GR (1)