Non-Invasive Plasma Treatment for Cervical Infections: Targeting High- and Low-Risk HPV Variants
Treatment of Infections of the Cervix Uteri With High- and Low-risk Variants of the Human Papillomavirus Using Non-invasive Physical Plasma
1 other identifier
observational
50
1 country
1
Brief Summary
This is a prospective, single-center, observational proof-of-principle clinical trial at the Department of Women's Health of the University Hospital Tübingen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 27, 2023
CompletedFirst Submitted
Initial submission to the registry
February 26, 2024
CompletedFirst Posted
Study publicly available on registry
March 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 26, 2026
April 1, 2025
2.7 years
February 26, 2024
January 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
HPV eradication rate
In the following intervention study, participants will be tested for HPV infection before and after NIPP treatment.
3-6 months
Secondary Outcomes (4)
Correlation of HPV Genotyping
During the study (12-24 months)
HPV-Quality-of-Life (HPV-QoL)
During the study (12-24 months)
Tissue Tolerance and Compatibility of NIPP Treatment
During the study (12-24 months)
Detection of Intracellular Molecular Plasma Mechanisms
During the study (12-24 months)
Study Arms (2)
NIPP treatment
Treatment with cold physical Plasma
Control group
No treatment with cold physical Plasma
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
- 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
You may not qualify if:
- Transformation zone not fully visible
- Evidence of invasive disease
- Serious cardiovascular diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Tuebingen, Department of Women's Health
Tübingen, 72076, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Weiss, Dr. med.
University Hospital Tuebingen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2024
First Posted
March 4, 2024
Study Start
December 27, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 26, 2026
Record last verified: 2025-04