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 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT02053766
Eligibility Criteria:
Inclusion Criteria:
* Subjects must fulfill the following inclusion criteria:
* Subject is informed and given ample opportunity to consider his/her participation and has given his/her written consent.
* Subject is willing and able to comply with all study requirements.
* Subject is between 0 - 17 years of age.
* Subject has been diagnosed with mitochondrial dysfunction based on modified Walker criteria.
* Subject is scheduled to have a non-emergent diagnostic or therapeutic procedure for routine medical care requiring general anesthesia estimated to last at least one hour.
* Subject is classified ASA I - IV
Exclusion Criteria:
Subjects are not permitted to enroll in the study if any of the following criteria are met:
* Subject is older than 17 years
* Subject is pregnant
* Subject is a nursing female and
* Subject has participated in the same study within 48 hours
* Subject is allergic or has had any adverse effect to any of the study agents in the past
* Anesthesia time is less than one hour
* Subject is classified ASA V
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
17 Years
Study:
NCT02053766
Study Brief:
Protocol Section:
NCT02053766