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 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT02881359
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 18 years of age at screening visit
2. Written informed consent obtained
3. Subject is scheduled to have or already underwent elective open, laparoscopic or robot assisted surgery involving the creation of a coloanal or colorectal anastomosis\* created within 15 cm from the anal verge.
4. Subject was already treated or is scheduled to be treated with LifeSeal® Kit, applied according to the IFU
Exclusion Criteria:
1\. Subject with American Society of Anesthesiology (ASA) status \> 3.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02881359
Study Brief:
Protocol Section:
NCT02881359