E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The scope of this trial is to evaluate if it is possible to apply TachoSil around colorectal anastomosis and evaluate its feasibility in future clinical trials. Therefore the only focus is on the validation of the TachoSil application method. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to evaluate if the application of TachoSil on a colorectal anastomosis is feasible and safe. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to establish and describe optimal application methods to be used for educational purposes in future trials. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Has the patient given informed consent according to local requirements before any trialrelated activities? A trial-related activity is any procedure that would not have been performed during the routine management of the subject 2. Is the subject 18 years of age or above? 3. Is the subject scheduled for elective resection of the rectum? 4. Is a colorectal anastomosis below the peritoneal reflexion planned?
For females of childbearing potential: 5. 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))? 6. Is the blood or urine pregnancy test negative? |
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E.4 | Principal exclusion criteria |
1. Is the subject scheduled for emergency resection of the rectum? 2. Does the subject suffer from inflammatory bowel diseases? 3. Does the subject have a history of hypersensitivity reactions after application of human fibrinogen, human thrombin and/or collagen of any origin? 4. Has the subject participated in any other trial with an investigational medical product (IMP) or device within 30 days before inclusion in this trial? 5. Does the subject participate or plan to participate in another clinical trial during the trial period?
For females of childbearing potential: 6. Is the subject pregnant or breast feeding? Exclusion - peroperative 7. Was an anastomosis performed differently from what was defined in the inclusion criteria? 8. Did the subject receive any fibrin sealant/glue, excluding TachoSil®, during surgery? |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is whether or not the TachoSil application is feasible. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |