Non-Invasive Plasma Treatment for Cervical Infections: Targeting High- and Low-Risk HPV Variants
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital Tuebingen
About this trial
This is a prospective, single-center, observational proof-of-principle clinical trial at the Department of Women's Health of the University Hospital Tübingen.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Transformation zone not fully visible
Evidence of invasive disease
Serious cardiovascular diseases
Trial population
The study includes patients aged 18 and over from the dysplasia clinic of the University Women's Hospital Tübingen who have been diagnosed with an infection of the cervix uteri involving both high- and low-risk HPV viruses.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Cold physical Plasma
Other interventionThe 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.
Control group
Other interventionA potential natural healing of the HPV infection will be anticipated
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: NIPP treatment1 intervention
Group B: Control group1 intervention
Trial outcomes
Primary outcomes
1
HPV eradication rate
In the following intervention study, participants will be tested for HPV infection before and after NIPP treatment.
Time frame
3-6 monthsSecondary outcomes
1
Correlation of HPV Genotyping
HPV genotyping is crucial for identifying specific viral strains. Correlation studies will be performed via obtained datasets and the application of statistical methods to identify associations among different HPV genotypes. The findings from this study will contribute to our understanding of the virus, guide health interventions, and improve clinical management strategies related to HPV infections.
Time frame
During the study (12-24 months)2
HPV-Quality-of-Life (HPV-QoL)
The HPV-Quality-of-Life (HPV-QoL) questionnaire is developed to determine the impact of HPV infection and related interventions on women health-related quality-of-life.
Time frame
During the study (12-24 months)3
Tissue Tolerance and Compatibility of NIPP Treatment
Cold plasma generates reactive oxygen and nitrogen species, electric fields, and other biologically active components that can interact with biological tissues. Assessing tissue tolerance and compatibility will be crucial for ensuring the safety and effectiveness of cold plasma treatment.
Time frame
During the study (12-24 months)4
Detection of Intracellular Molecular Plasma Mechanisms
The detection of intracellular molecular plasma mechanisms refers to the identification and study of processes and mechanisms that take place within cells through the interaction with so-called plasma, especially cold plasma. The detection of intracellular molecular plasma mechanisms refers to the identification and study of processes that take place within cells through the interaction with plasma, especially cold plasma. Interaction of cold plasma with cellular mechanisms will be studied via routine molecular biological methodology.
Time frame
During the study (12-24 months)Sponsors and contacts
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Source ClinicalTrials.gov