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This clinical trial is to evaluate the effectiveness and the safety of high intensity focused ultrasound (HIFU) in the treatment of benign thyroid nodules.
Full description
This clinical trial is a prospective, multicentre, randomized, controlled study of high intensity focused ultrasound (HIFU) treatment of benign thyroid nodules. this study will include 240 patients with benign thyroid nodules that meet all ths the inclusion / exclusion criteria and will be randomly divided into two groups at 1: 1 ratio. Patients in the test group will be treated with high intensity focused ultrasound (HIFU), while patients in the control group will be actively observed and followed up by ultrasound examination. The primary objective of this clinical trial is to evaluate the efficacy of the test device in the treatment of benign thyroid nodules, and the secondary objective is to evaluate the safety of the test device in the treatment of benign thyroid nodules and the improvement of symptoms assessed by VAS score.
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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:
If there are more than one nodule on the treatment side, all of the following conditions shall be met:
If there are nodules on the opposite side of HIFU treatment side, one of the following conditions shall be met:
Absence of abnormal vocal cord mobility at laryngoscopy.
Patients reject or cannot tolerate invasive surgical treatment.
Patient has signed a written informed consent.
Exclusion criteria
Primary purpose
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Interventional model
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240 participants in 2 patient groups
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Central trial contact
Yao Zhong, Master
Data sourced from clinicaltrials.gov
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