NCT02246504已完成不适用
Registry - 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
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline in thyroid nodule's volume
研究概览
简要总结
The purpose of this study is to evaluate thyroid nodule's volume, structure and vascularisation changes following HIFU therapy assessed by ultrasonography
详细描述
HIFU treatment will be performed under conscious sedation under the supervision / responsibilities of an anesthetist.
A maximum of 2 HIFU sessions per nodule will be performed per patient. The decision to retreat the patient will be taken at 1 month post-HIFU or later.
Follow-up after HIFU treatment
D1 after HIFU session:
- Indirect laryngoscopy to check vocal cord mobility.
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 FNAB from the last 6 months
- •Normal serum calcitonin
- •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
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 IV neurolept analgesia.
研究组 & 干预措施
HIFU treatment
Experimental
use of HIFU treatment in patients with non-malignant thyroid nodules
干预措施: HIFU treatment (Device)
结局指标
主要结局
Change from baseline in thyroid nodule's volume
时间窗: Month 6
次要结局
- Number of participants with adverse events(D1, D7, M1, M3 and M6)
- Change from baseline in thyroid nodule's structure and vascularisation(Month 6)
研究者
研究点 (2)
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