Treatment of Benign Thyroid Nodules With FastScan High Intensity Focused Ultrasound (HIFU)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Theraclion
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day
研究概览
简要总结
This study evaluates the efficacy of the HIFU for the treatment of benign thyroid nodules with the FastScan version using assessment of patient experience and adverse event reporting.
详细描述
Echopulse is specially designed, manufactured and CE marked for treating benign thyroid nodules. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.
In a previous european feasibility study performed at 1 site (Bulgaria), 20 benign thyroid nodules were treated. The HIFU treatment was well tolerated and showed efficacy.
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 (fine-needle aspiration biopsy) from the last 6 months
- •Normal serum calcitonin
- •No history of neck irradiation
- •Normal TSH (thyroid-stimulating hormone)
- •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) : predominantly solid
- •Patient has signed a written informed consent.
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.
结局指标
主要结局
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day
时间窗: 1 day post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days
时间窗: 7 days post treatment
Patient satisfaction questionnaire
时间窗: 6 months post treatment
Number of participants with adverse events
时间窗: 7 days post treatment
Change in volume of the thyroid nodule compared to Baseline at 6 months
时间窗: 6 months post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days
时间窗: 3 days post treatment
次要结局
- Number of patients with Absence of palpable lesion(6 months post treatment)
- Change from Baseline of gland vascularization at 6 months(6 months post treatment)
- Patient Cosmetic evaluation measured by questionnaire(6 months post treatment)
- Investigator rated evaluation of the device(Post treatment Day 0)
- Change from Baseline of gland vascularization at 3 months(3 months post treatment)