NCT07226804招募中不适用
Nanosecond Pulsed Field Ablation in the Management of Benign Thyroid Nodules
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Quality-of-life Questionnaire
研究概览
简要总结
To observe the outcomes of nsPFA therapy to treat benign thyroid nodules.
详细描述
Primary Objectives
• To evaluate the thyroid nodule volume changes over time in participants undergoing nsPFA as part of routine clinical care
Secondary Objectives
- To determine changes in health-related quality of life changes following ultrasound-guided nsPFA
- To evaluate the ultrasound features of thyroid nodules over time following ultrasound-guided nsPFA.
- To assess the incidence and nature of complications following ultrasound-guided nsPFA, categorized into Minor and Major complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Eligibility Criteria
- •Scheduled to undergo ultrasound guided nsPFA as standard of care
- •Age 18 to 80 years.
- •Capable of providing independent consent.
- •Presence of biopsy-confirmed benign thyroid nodule , defined as one of the following:
- •Benign FNA X 2 or
- •Benign US guided FNA X 1 + benign thyroid nodule ultrasound appearance (TI-RADS 2) or
- •Benign FNA X 1 and radiographic/laboratory evidence of functional nature
- •Nodule measuring >2cm in greatest dimension
- •Presence of compressive symptoms reasonably attributable to thyroid nodule (i.e. pressure sensation, dysphagia, dysphonia, respiratory distress)
- •No abnormal cervical lymph nodes during screening visit .
排除标准
- •Patients considered unsuitable for nsPFA by the treating physician
结局指标
主要结局
Quality-of-life Questionnaire
时间窗: Through study completion; an average of 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
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