- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00713661
Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)
Non-randomised, Open, Multi-center Trial Evaluating Feasibility and Safety of TachoSil® Application on a Colorectal Anastomosis.
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 to be used for educational purposes in future trials.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Berlin, Germany
- Investigational Site
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Utrecht, Netherlands
- Investigational Site
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Kent
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Dartford, Kent, United Kingdom
- Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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?
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: TachoSil®
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Sterile, ready-to-use, absorbable sponge for intra-operative topical application. It consists of an equine collagen sponge coated with the fibrin glue components human fibrinogen and human thrombin. Surgery was performed according to the hospitals' local standards. When the anastomosis was performed, all enrolled subjects had TachoSil® applied around the anastomotic line. TachoSil® was therefore an add-on therapy. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor
Time Frame: Day of surgery
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Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis.
A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm.
The score was assisted by video recording.
To ensure an independent assessment, the recording was assessed by an external, blinded assessor.
In case of discrepancies between the assessment of the investigator and the assessor, the application was regarded as not feasible.
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Day of surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator.
Time Frame: Day of surgery
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Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis.
A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm.
The score was assisted by video recording.
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Day of surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TC-029-IM
- 2007-007254-62 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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