Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-24 @ 12:04 PM
NCT ID:
NCT00713661
Eligibility Criteria:
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?
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00713661
Study Brief:
Protocol Section:
NCT00713661