NCT02258347已完成不适用
Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Theraclion
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Evaluation of thyroid nodule's structure changes following HIFU therapy assessed by ultrasonography (US)
研究概览
简要总结
Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient 18 years or older.
- •Patient presenting with at least one thyroid nodule with no signs of malignancy:
- •Non suspect clinically and at ultrasonography imaging
- •Benign cytological diagnosis at fine-needle aspiration biopsy (FNAB) from the last 6 months
- •Normal serum calcitonin
- •No history of neck irradiation
- •Normal thyroid-stimulating hormone (TSH).
- •Targeted nodule accessible and eligible to HIFU
- •Absence of abnormal vocal cord mobility at laryngoscopy.
- •Nodule diameter ≥ 10mm measured by ultrasound.
- •Nodule volume inferior to 10 cc
- •Composition of the targeted nodule(s) : no more than 30% cystic
排除标准
- •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 the assigned analgesia/anaesthesia.
研究组 & 干预措施
Single arm
Experimental
干预措施: Echopulse (Device)
结局指标
主要结局
Evaluation of thyroid nodule's structure changes following HIFU therapy assessed by ultrasonography (US)
时间窗: Month 6 and Month 12
Evaluation of thyroid nodule's vascularisation changes following HIFU therapy assessed by ultrasonography (US)
时间窗: Month 6 and Month 12
Evaluation of thyroid nodule's volume changes following HIFU therapy assessed by ultrasonography (US)
时间窗: Month 6 and Month 12
次要结局
- Number of subjects with adverse events as a measure of safety and tolerability(Day 1, Month 1, Month 3, Month 6 and Month 12)
研究者
研究点 (2)
Loading locations...
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