Overview
This is a prospective, single-center, observational proof-of-principle clinical trial at the Department of Women's Health of the University Hospital Tübingen.
Description
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.
Eligibility
Inclusion Criteria:
- 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
Exclusion criteria:
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