NCT03218436已完成不适用
Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Pathological remission of cervical intraepithelial neoplasia
研究概览
简要总结
Cervical intraepithelial neoplasia will be treated with physical low temperature plasma in the plasma cohort compared to watchful waiting in the control cohort.
Primary endpoint after 3-6 months: Pathological remission.
Secondary endpoint: HPV remission.
详细描述
The study was completed with Less recruitment as it was planned due to overwhelming study success. The study was published in August 2023. A link has been added to the Reference section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed CIN I / II
- •Reliable assessment of the radius of the portio and marginal borders of the lesions
- •Written consent for treatment with low temperature plasma after reconnaissance
- •Inclusion Criteria for Control-Group:
- •Histologically confirmed CIN I / II
- •Reliable assessment of the radius of the portio and marginal borders of the lesions
- •Patients who want a waiting procedure and a control examination after 3-6 months
排除标准
- •Histologically confirmed CIN III
- •Not fully visible transformation zone
- •An indication of invasive disease
- •Expected lack of compliance of the patient or incapacity of the patient to understand the meaning and purpose of the clinical trial
- •Severe cardio-vascular disease
- •Lack of patient consent
研究组 & 干预措施
CAP cohort
Active Comparator
Cold Atmospheric plasma intervention
干预措施: CAP treatment (Procedure)
Control cohort
No Intervention
no intervention
结局指标
主要结局
Pathological remission of cervical intraepithelial neoplasia
时间窗: 3-6 months
Biopsy, Histopathological examination
次要结局
- Comfort / Dyscomfort during intervention(Immediately, 2 week, 3-6 months)
- Human papilloma virus remission rate(3-6 months)
研究者
研究点 (1)
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