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

U

University Hospital Tuebingen

Status

Enrolling

Conditions

HPV Infection
Cervical Cancer

Treatments

Other: Control group
Other: Cold physical Plasma

Study type

Observational

Funder types

Other

Identifiers

NCT06291311
MT_NIPP-HPV_ERBE

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

NIPP treatment
Description:
Treatment with cold physical Plasma
Treatment:
Other: Cold physical Plasma
Control group
Description:
No treatment with cold physical Plasma
Treatment:
Other: Control group

Trial contacts and locations

1

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Central trial contact

Martin Weiss, Dr. med.

Data sourced from clinicaltrials.gov

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