Evaluation of the Thyroid Volume After Radiofrequency Ablation of Thyroid Nodules and Recurrent Thyroid
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The primary objective of the study is to demonstrate reduction of thyroid volume following radiofrequency ablation of thyroid tissue
研究概览
简要总结
Thyroid nodules are among the common alterations of the thyroid. Depending on the detection method the prevalence is between 20% and 50%, whereas the incidence increases with improvement of ultrasonic technology. The CelonPro Surge bipolar coagulation electrode operated with the compatible power control unit and compatible tube pump is indicated for ablation and coagulation of soft tissue, including thermal inactivation and/or volume reduction of locally defined tissue areas, such as tumors and metastases.
The primary objective of the study is to assess the influence of radiofrequency ablation due to thyroid volume after 24 hours, 3 months, 6 months and 1 year.
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
- •The patient must have given written (personally signed and dated) informed consent before completing any study-related procedures (i.e. any assessment or evaluation that would not have formed part of their normal medical care).
- •The patient must be aged 18yrs or older.
- •The patient must be able to understand, and be willing to comply with the requirements of the protocol
- •The patient is not pregnant
- •The patient has the diagnosis of benign thyroid nodules, struma diffusa, struma uninodosa, struma multinodosa, struma per magna, Thyroidea nodosa or Thyroidea multinodosa
- •The patient rejected surgery The patient rejected sole radioiodine therapy
排除标准
- •Malign nodules
- •Pregnancy
- •Pacemaker near the target issue (<4cm)
- •Nerve stimulating device
- •High fever
- •Prosthesis for the inner ear
研究组 & 干预措施
Celon Pro Surge
Ablation of thyroid tissue
干预措施: Celon Pro Surge (Device)
结局指标
主要结局
The primary objective of the study is to demonstrate reduction of thyroid volume following radiofrequency ablation of thyroid tissue
时间窗: 1 year
The primary endpoint is the reduction of thyroid volume at 12-Month follow-up visit. A responder to the radiofrequency treatment is defined as a subject with any reduction of the thyroid volume.
次要结局
未报告次要终点