NCT01060982已完成不适用
Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU)Treatment Procedure: A Monocentre, Open, Uncontrolled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Theraclion
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Histology of excised gland.
研究概览
简要总结
This study is a multicentre, open, uncontrolled trial for the observation of histological changes in parathyroid adenomas following high intensity focused ultrasound (HIFU).
This study will be conducted in France in 10 patients with primary hyperparathyroidism scheduled for a parathyroidectomy. The patient will receive an HIFU treatment in the center of the adenoma before the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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.
- •Patients with diagnosed primary hyperparathyroidism (clinical symptoms and/or biochemical disturbances) scheduled for parathyroidectomy.
- •One diseased parathyroid gland, visualized by ultrasonography.
- •The diseased targeted parathyroid gland accessible for HIFU treatment (anonymised ultrasonographic images to be sent to the sponsor's technical team for validation).
- •Normal pretreatment nasofibroscopy.
- •Voluntary signed informed consent.
排除标准
- •Inaccessibility or high risk of targeting neighbouring structures, as evidenced by:
- •Targeted area located less than 2 mm laterally from the oesophagus or the carotid artery
- •Targeted area located less than 3 mm laterally from the trachea,
- •Significant hyperechoic area with a posterior shadow located less than 10 mm behind the targeted area (behind to be understood as posterior to the targeted area in the direction of the HIFU beam)
- •Investigator appreciation of any abnormal blood test that could contraindicate treatment with HIFU (bleeding abnormalities)
- •Known spondylitis of the neck vertebrae
- •Head and/or neck disease that prevents hyperextension of neck.
- •Known history of parathyroid or other neoplasias in the neck region.
- •History of neck irradiation
- •Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit
- •Pregnant or lactating woman.
- •Female patient of childbearing age if not having a suitable contraception method.
- •Patients who have received any investigational drug or device within the last 15 days and/or patients who are currently participating in another clinical trial.
结局指标
主要结局
Histology of excised gland.
时间窗: After surgery performed the same day as High intensity focused ultrasound treatment
次要结局
未报告次要终点
研究者
研究点 (4)
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