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HIFU Treatment of Benign Thyroid Nodules

240 participantsStarted 2024-08

Plain-language summary

This clinical trial is to evaluate the effectiveness and the safety of high intensity focused ultrasound (HIFU) in the treatment of benign thyroid nodules.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Male or female patients older than 18 years and younger than 70 years
✓. No history of neck irradiation
✓. Normal thyroid function, serum calcitonin level, PTH and serum calcium at screening visit examination.
✓. No abnormal cervical lymph nodes during screening visit examination.
✓. The target thyroid nodule must meet all of the following conditions:
✓. Single nodule, 2cm≤max diameter≤4cm
✓. Causing appearance , pressure or swallowing symptoms
✓. Composition of target nodule: solid or predominantly solid (solid area≥80%)

Exclusion criteria

✕. The ultrasound report indicated that follicular tumors were not excluded.
✕. Known history of thyroid cancer or other neoplasias in the neck region.
✕. Head and/or neck disease that prevents hyper-extension of neck.
✕. Patients currently in the acute phase of any disease.
✕. History of head and neck, pulmonary and systemic infections in the last 2 weeks.
✕. The white blood cell test result exceeded the upper limit of the normal range.
✕. Tenderness of the thyroid and/or thyroid nodules.
✕. History of arrhythmia, coronary heart disease or valvular heart disease, heart failure.

What they're measuring

Effectiveness evaluation using treatment effective rate

Timeframe: 12 Months

Trial details

NCT IDNCT04233398

SponsorTheraclion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11

Contact for this trial

Yao Zhong, Master

+860755-21659096 joanna.zhong@theraclion.com

View on ClinicalTrials.gov More Thyroid Nodule (Benign) trials