Non-Invasive Plasma Treatment for Cervical Infections: Targeting High- and Low-Risk HPV Variants

NCT ID: NCT06291311

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-27

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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HPV Infection Cervical Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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NIPP treatment

Treatment with cold physical Plasma

Cold physical Plasma

Intervention Type OTHER

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 group

No treatment with cold physical Plasma

Control group

Intervention Type OTHER

A potential natural healing of the HPV infection will be anticipated

Interventions

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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.

Intervention Type OTHER

Control group

A potential natural healing of the HPV infection will be anticipated

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Transformation zone not fully visible
* Evidence of invasive disease
* Serious cardiovascular diseases
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Weiss, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

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University Hospital Tuebingen, Department of Women's Health

Tübingen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Martin Weiss, Dr. med.

Role: CONTACT

+497071 29 82211

Facility Contacts

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Martin Weiss, Dr. med.

Role: primary

+4970712982211

Other Identifiers

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MT_NIPP-HPV_ERBE

Identifier Type: -

Identifier Source: org_study_id

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