Evaluation of Low-thermal Argon Plasma Devitalization (LtAPD) for the Treatment of Cervical Intraepithelial Neoplasia (CIN) Grade 2 Versus Standard of Active Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Histopathological remission of CIN 2
研究概览
简要总结
The study aims to show that treatment with LtAPD works better than a sham treatment or simply monitoring the condition closely without active treatment ("active surveillance"), in achieving complete healing of a tissue abnormality on the cervix called CIN 2, after 6 months. This will be confirmed by examining tissue samples under a microscope (histopathological examination).
详细描述
Participation in the study lasts 6 months. Eligible participants are randomly assigned to one of two groups: participants receiving LtAPD treatment (treatment group) or participants receiving a sham procedure, in which LtAPD treatment is simulated but not actually applied (control group). All participants continue to be managed according to the current standard of care, active surveillance with regular monitoring, throughout the study. Participants remain blinded to their treatment assignment. The study includes four visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex
- •Age 18 - 40 years at the time of signing the informed consent
- •Histologically confirmed CIN 2
- •Full visibility of the entire transformation zone (Type 1 or Type 2) and entire lesion in colposcopy
- •Ability to understand the nature of the clinical investigation and voluntarily signs the informed consent document prior to any study-related procedures
排除标准
- •Histologically confirmed CIN other than CIN 2, or indication of (micro-) invasive cervical disease
- •CIN lesions extending to the vaginal vault or suspicion of endocervical disease
- •Current pregnancy or planned pregnancy within the next 6 months
- •Presence of severe local inflammation or active infection
- •Presence of a severe cardiovascular, neurological, psychiatric, endocrine, or hematological disease, immunocompromised condition or malignant tumor of any origin, as judged by the investigator
- •Participation in an interfering clinical study, as judged by the investigator
研究组 & 干预措施
LtAPD
Treatment with low-thermal argon plasma devitalization
干预措施: Treatment with low-thermal argon plasma devitalization (Device)
Sham
Sham treatment
干预措施: Sham treatment (Device)
结局指标
主要结局
Histopathological remission of CIN 2
时间窗: at 6 months
Percentage of patients with histopathologically confirmed remission of CIN 2 (absence of CIN 2 or higher grade lesion), assessed by cervical biopsy/histopathological evaluation
次要结局
- HPV remission rate(at 6 months)
- Cytological remission of CIN(at 6 months)
- Quality of life, comfort/ discomfort of the treatment procedure and sexual activity(at baseline, intervention, 6 months)
- Correlation of electrosurgical unit (ESU) and video data with CIN remission and applied argon plasma(at 6 months)