HPV InfectionNCT06291311
Non-Invasive Plasma Treatment for Cervical Infections: Targeting High- and Low-Risk HPV Variants
An observational study of HPV Infection and Cervical Cancer, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HPV Infection, Cervical Cancer
- What is being tested?
- Cold physical Plasma
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 27 Dec 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tuebingen, Department of Women's Health
Tübingen, 72076
Martin Weiss, Dr. med., +4970712982211, martin.weiss@med.uni-tuebingen.de
About this study
Official title: Treatment of Infections of the Cervix Uteri With High- and Low-risk Variants of the Human Papillomavirus Using Non-invasive Physical Plasma
This is a prospective, single-center, observational proof-of-principle clinical trial at the Department of Women's Health of the University Hospital Tübingen.
Read the 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.
- Conditions
- HPV Infection, Cervical Cancer
- Being tested
- Cold physical Plasma, Control group
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold physical PlasmaOther
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.
Control groupOther
A potential natural healing of the HPV infection will be anticipated
| Study group | Role | What they receive |
|---|---|---|
| NIPP treatment | Treatment with cold physical Plasma Receives: Other: Cold physical Plasma | |
| Control group | No treatment with cold physical Plasma Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV eradication rate
In the following intervention study, participants will be tested for HPV infection before and after NIPP treatment.
Measured: 3-6 months
Secondary outcomes (4)
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.
Measured: During the study (12-24 months)
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.
Measured: During the study (12-24 months)
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.
Measured: During the study (12-24 months)
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.
Measured: During the study (12-24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start27 Dec 2023
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Weiss, Dr. med., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291311
- Sponsor's protocol ID
- MolGyn_NIPP-HPV_ERBE
- Status last verified
- Jun 2026
- First submitted
- 26 Feb 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Infections of the Cervix Uteri With High- and Low-risk Variants of the Human Papillomavirus Using Non-invasive Physical Plasma
- ClinicalTrials.gov ID
- NCT06291311
- Acronym / sponsor ID
- MolGyn_NIPP-HPV_ERBE
- Conditions
- HPV Infection, Cervical Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIPP treatment | – | Other: Cold physical PlasmaTreatment with cold physical Plasma |
| Control group | – | Other: Control groupNo treatment with cold physical Plasma |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (8 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold physical PlasmaThe 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 | NIPP treatment |
| Control groupA potential natural healing of the HPV infection will be anticipated | Other | Control group |
Primary outcome
HPV eradication rate
Time frame: 3-6 months
In the following intervention study, participants will be tested for HPV infection before and after NIPP treatment.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Weiss, Dr. med. principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV Infection and Cervical Cancer, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Weiss, Dr. med. (+497071 29 82211, martin.weiss@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV eradication rate (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.