Non-Invasive Plasma Treatment for Cervical Infections: Targeting High- and Low-Risk HPV Variants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cold physical Plasma, Control group.
- Who it may be relevant to
- Registry conditions: HPV Infection, Cervical Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Treatment of Infections of the Cervix Uteri With High- and Low-risk Variants of the Human Papillomavirus Using Non-invasive Physical Plasma
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.
Detailed 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.
Interventions
- Other Cold physical Plasma
The treatment is administered by either the supervising specialists or assistant doctors at the University Women's Hospital, under their supervision and authorization. It's important to note that the NIPP treatment is designed to be relatively brief, with a duration not exceeding 10-20 minutes. - Other Control group
A potential natural healing of the HPV infection will be anticipated
Primary outcome measures
- HPV eradication rate [Time frame: 3-6 months]
Secondary outcome measures (4)
- Correlation of HPV Genotyping [Time frame: During the study (12-24 months)]
- HPV-Quality-of-Life (HPV-QoL) [Time frame: During the study (12-24 months)]
- Tissue Tolerance and Compatibility of NIPP Treatment [Time frame: During the study (12-24 months)]
- Detection of Intracellular Molecular Plasma Mechanisms [Time frame: During the study (12-24 months)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Germany · 1 center
- University Hospital Tuebingen, Department of Women's Health — Tübingen
Identifiers
NCT: NCT06291311 · MolGyn_NIPP-HPV_ERBE