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:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2025-12-26 @ 3:58 PM
NCT ID:
NCT02227706
Eligibility Criteria:
Inclusion Criteria:
* Paediatric subjects birth to \<18 years of age, requiring non-emergent laparoscopic or open (through peritoneum or pleura) abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures. i) The first 36 subjects to be enrolled will be subjects ≥1 years to \<18 years of age. ii) The next 4 subjects to be enrolled will be subjects birth to \<1years of age.
* The subject and/or subject's parent or legal guardian must be willing to give permission for the subject to participate in the trial, and provide written informed consent for the subject. If possible, assent must be obtained from paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the paediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the trial), the parent/legal guardian's written informed consent for the subject will be acceptable for the subject to be included in the study; and
* Presence of an appropriate mild or moderate bleeding soft tissue or parenchymal organ Target Bleeding Site identified intra-operatively by the surgeon;
Exclusion Criteria:
* Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
* Female subjects, who are of childbearing age (i.e. adolescent), who are pregnant or nursing;
* Subject is currently participating or, during the study is planned to participate in any other investigational device or drug trial without prior approval from the Sponsor;
* Subjects who are known, current alcohol and/or drug abusers;
* Subjects admitted for trauma surgery;
* Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
* Subjects with Target Bleeding Site in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
* Anastomotic bleeding sites will not be considered for randomization.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT02227706
Study Brief:
Protocol Section:
NCT02227706