Status:
COMPLETED
Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)
Lead Sponsor:
Nycomed
Conditions:
Colorectal Anastomosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective is to evaluate if the application of TachoSil® on a colorectal anastomosis is feasible and safe. The secondary objective is to establish and describe optimal application methods...
Eligibility Criteria
Inclusion
- Inclusion Criteria - at screening:
- Has the patient given informed consent according to local requirements before any trial-related activities? A trial-related activity is any procedure that would not have been performed during the routine management of the subject.
- Is the subject 18 years of age or above?
- Is the subject scheduled for elective resection of the rectum?
- Is a colorectal anastomosis below the peritoneal reflexion planned?
- For females of childbearing potential:
- Does the patient use an acceptable contraceptive method (contraceptive pills, injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices, transdermal patches or intrauterine device (IUD))?
- Is the blood or urine pregnancy test negative?
- Exclusion Criteria -at screening:
- Is the subject scheduled for emergency resection of the rectum?
- Does the subject suffer from inflammatory bowel diseases?
- Does the subject have a history of hypersensitivity reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
- Has the subject participated in any other trial with an investigational medical product (IMP) or device within 30 days before inclusion in this trial?
- Does the subject participate or plan to participate in another clinical trial during the trial period?
- For females of childbearing potential:
- • Is the subject pregnant or breast feeding?
- Exclusion - peroperative
- Was an anastomosis performed differently from what was defined in the inclusion criteria?
- Did the subject receive any fibrin sealant/glue, excluding TachoSil® , during surgery?
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00713661
Start Date
June 1 2008
End Date
July 1 2010
Last Update
May 8 2012
Active Locations (3)
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1
Investigational site
Berlin, Germany
2
Investigational site
Utrecht, Netherlands
3
Investigational site
Dartford, Kent, United Kingdom