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:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT03266094
Eligibility Criteria:
Inclusion Criteria:
1. Children and adolescent subjects 2-12 years of age at the time of the procedure, inclusive
2. Scheduled to undergo tonsillectomy
3. The subject and subject's Legally Authorized Representative (LAR) is willing to participate and consents to participate, as documented by signed informed consent form and/ or assent form (as applicable)
Exclusion Criteria:
1. Subjects undergoing:
1. Tonsillectomy as a result of cancer
2. Unilateral tonsillectomy
2. Subjects with:
1. Known Bleeding disorders
2. History of peritonsillar abscess
3. Craniofacial disorders
4. Down's syndrome (Trisomy 21)
5. Cerebral palsy
6. Major heart disease (including but not limited to; right-sided heart failure, left-sided heart failure, congestive heart failure, coronary artery disease, arrhythmias, chronic heart failure, acute heart failure, etc.)
7. Current tobacco use
3. Subjects unable to comply with the required study follow-up visits
4. Female subjects pregnant at time of procedure
5. The subject has comorbidities which, in the opinion of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months.
6. The subject is participating or has participated in any drug or device research study within 30 days of enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
12 Years
Study:
NCT03266094
Study Brief:
Protocol Section:
NCT03266094