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NCT Number: NCT06291311

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

This is a prospective, single-center, observational proof-of-principle clinical trial at the Department of Women's Health of the University Hospital Tübingen.

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Key information

Conditions

HPV Infection Cervical Cancer Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Tuebingen, Department of Women's Health

Tübingen, 72076, Germany

Location status: Recruiting

Location contact

Martin Weiss, Dr. med.

CONTACT

[email protected]

+4970712982211

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold physical Plasma

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

Other

A potential natural healing of the HPV infection will be anticipated

Primary outcomes

  1. 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.

Secondary outcomes

  1. Correlation of HPV Genotyping

    Time frame: During the study (12-24 months)

    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.

  2. HPV-Quality-of-Life (HPV-QoL)

    Time frame: During the study (12-24 months)

    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.

  3. Tissue Tolerance and Compatibility of NIPP Treatment

    Time frame: During the study (12-24 months)

    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.

  4. Detection of Intracellular Molecular Plasma Mechanisms

    Time frame: During the study (12-24 months)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Weiss, Dr. med.

CONTACT

[email protected]

+497071 29 82211

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Treatment of Infections of the Cervix Uteri With High- and Low-risk Variants of the Human Papillomavirus Using Non-invasive Physical Plasma

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2024
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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