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 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT03600168
Eligibility Criteria:
Main Inclusion Criteria:
* Male or female patient ≥ 18 years old
* Subject have been informed and understand the nature and extent of the study, agree to its provisions and have provided written approved informed consent
* Patient undergoing elective primary or redo open liver resection for hepatic colorectal metastases with a curative intent
* Subject, who, in the opinion of the Clinical Investigator, is able to understand this clinical study, cooperate with the study procedures and is willing to return for the required post-treatment follow-up.
Main Exclusion Criteria:
* Known allergy or hypersensitivity to any component of the investigational treatment PuraStat®
* Pregnant or interested in becoming pregnant during the duration of the study, or breast feeding
* Concurrent participation in another clinical study with a medical device or medicinal product with interfering endpoints
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03600168
Study Brief:
Protocol Section:
NCT03600168