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 @ 9:20 PM
Ignite Modification Date:
2025-12-24 @ 9:20 PM
NCT ID:
NCT02246504
Eligibility Criteria:
Inclusion Criteria:
* Male or female patient 18 years or older.
* Patient presenting with at least one thyroid nodule with no signs of malignancy:
1. Non suspect clinically and at ultrasonography imaging
2. Benign cytological diagnosis at FNAB from the last 6 months
3. Normal serum calcitonin
4. No history of neck irradiation
* Normal TSH.
* Targeted nodule accessible and eligible to HIFU
* Absence of abnormal vocal cord mobility at laryngoscopy.
* Nodule diameter ≥ 10mm measured by ultrasound.
* Composition of the targeted nodule(s) : no more than 30% cystic
Exclusion Criteria:
* Head and/or neck disease that prevents hyperextension of neck.
* Known history of thyroid cancer or other neoplasias in the neck region.
* History of neck irradiation.
* Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment
* Posterior position of the nodule if the thickness of the nodule is \<15mm
* Pregnant or lactating woman
* Any contraindication to IV neurolept analgesia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02246504
Study Brief:
Protocol Section:
NCT02246504