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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT01193556
Eligibility Criteria:
Inclusion Criteria:
1. Children \& adolescents: Age 3-17; Adults: 18 and older
2. Physically healthy, stable weight
3. Requiring tonsillectomy and adenoidectomy per widely accepted indications
4. For adults, subject must understand the nature of the procedure and provide written informed consent.
5. For children and adolescents age 7 to 17, subject must understand the nature of the procedure and be able to give verbal assent prior to the procedure. In addition, parent or guardian must provide written informed consent.
6. For children under 7 years old, parent or guardian must understand the nature of the procedure and provide written informed consent.
7. Subject (or responsible parent or guardian) must be willing and able to comply with all follow-up evaluations, including completion of study data sheets.
Exclusion Criteria:
1. Children: Age 2 and under
2. Bleeding disorder
3. Peritonsillar abscess
4. Requiring concomitant uvulopalatopharyngoplasty (UPPP)
5. Anticoagulation therapy which cannot be discontinued
6. Unable to follow instructions or complete follow-up
7. Currently taking any medication known to affect healing
8. Currently enrolled in another investigational device or drug trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT01193556
Study Brief:
Protocol Section:
NCT01193556