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

This study has been completed.
Sponsor:
Collaborator:
novoGI
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00880984
First received: April 13, 2009
Last updated: January 6, 2010
Last verified: July 2009

April 13, 2009
January 6, 2010
June 2008
September 2009   (final data collection date for primary outcome measure)
Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc [ Time Frame: 3-months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00880984 on ClinicalTrials.gov Archive Site
Not Provided
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Compression Anastomosis Using the Compression Anastomosis Ring (CAR™ 27)
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Surgery
Device: Compression Anastomosis Ring: CAR™ 27
Creation of anastomosis in colorectal surgeries using CAR™ 27
Other Name: CAR™ 27
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
Not Provided
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00880984
08-CAR-07-Gr-01
No
Prof. Spyros Papavramidis, AHEPA university Hospital of Thessaloniki
Aristotle University Of Thessaloniki
novoGI
Principal Investigator: Spiros Papavramidis, Prof. AHEPA University Hospital of Thessaloniki
Aristotle University Of Thessaloniki
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP