Treatment of Infections of the Cervix Uteri With High- and Low-risk Variants of the Human Papillomavirus Using Non-invasive Physical Plasma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- HPV eradication rate
研究概览
简要总结
This is a prospective, single-center, observational proof-of-principle clinical trial at the Department of Women's Health of the University Hospital Tübingen.
详细描述
The aim of this study is to investigate the HPV (Human papillomavirus)-eradicating efficacy of NIPP (non-invasive physical plasma) in patients with confirmed HPV infection but without cervical dysplasia. Another objective is to examine cellular/molecular/immunological effects of NIPP on the cervix through molecular biological methods following in-vivo treatment. Tissue samples will be obtained at defined intervals via minibiopsy, and analyses will be conducted using molecular biological, histological, and microscopic methods, potentially in collaboration with other research institutes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Inclusion criteria for NIPP treatment
- •Age ≥ 18 years
- •mRNA or DNA-based virus detection by smear (also external findings)
- •Clearly visible transformation zone of the cervix and margins of the lesions corresponding to T1/T2
- •Written informed consent to participate in the study
- •Inclusion criteria for control group
- •Age ≥ 18 years
- •Swab-based mRNA or DNA-based virus detection (also external findings)
- •Clearly visible transformation zone of the cervix corresponding to T1/T2
- •Written informed consent to participate in the study
排除标准
- •The following exclusion criteria apply to both groups of patients (NIPP treatment and control group).
- •Transformation zone not fully visible
- •Evidence of invasive disease
- •Serious cardiovascular diseases
研究组 & 干预措施
NIPP treatment
Treatment with cold physical Plasma
干预措施: Cold physical Plasma (Other)
Control group
No treatment with cold physical Plasma
干预措施: Control group (Other)
结局指标
主要结局
HPV eradication rate
时间窗: 3-6 months
In the following intervention study, participants will be tested for HPV infection before and after NIPP treatment.
次要结局
- Correlation of HPV Genotyping(During the study (12-24 months))
- HPV-Quality-of-Life (HPV-QoL)(During the study (12-24 months))
- Detection of Intracellular Molecular Plasma Mechanisms(During the study (12-24 months))
- Tissue Tolerance and Compatibility of NIPP Treatment(During the study (12-24 months))