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 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT06973928
Eligibility Criteria:
Inclusion Criteria:
* Age: 3 to 7 years old
* Received a surgical indication for adenotonsillectomy
* Beneficiary of the French single-payer national medical insurance system
* Informed consent given
* Able to attend all scheduled visits and comply with all trial procedures.
Exclusion Criteria:
* Previous adenotonsillectomy
* Subject has already participated in the current study
* Craniofacial malformation syndrome
* BMI according to age \> 97th percentile
* Previous or current stimulant medication (methylphenidate)
* Current orthodontic treatment
* Asymmetric score of the tonsil with a tonsil Brodsky score of ≤2
* Subject who are in a dependency or employment with the sponsor or the investigator
* Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
7 Years
Study:
NCT06973928
Study Brief:
Protocol Section:
NCT06973928