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

Recruiting

• Conditions: HPV Infection; Cervical Cancer
• Interventions: Other: Cold physical Plasma; Other: Control group

• Registration Number: NCT06291311
• Lead Sponsor: University Hospital Tuebingen

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.

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 Timeline

• Study Start: 2023-12-27
• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-03-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NIPP treatment	Cold physical Plasma	Treatment with cold physical Plasma
Control group	Control group	No treatment with cold physical Plasma

Primary Outcome Measures

Name	Time	Method
HPV eradication rate	3-6 months	In the following intervention study, participants will be tested for HPV infection before and after NIPP treatment.

Secondary Outcome Measures

Name	Time	Method
Correlation of HPV Genotyping	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.
HPV-Quality-of-Life (HPV-QoL)	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.
Detection of Intracellular Molecular Plasma Mechanisms	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.
Tissue Tolerance and Compatibility of NIPP Treatment	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.

Trial Locations

Locations (1)

University Hospital Tuebingen, Department of Women's Health; 🇩🇪 Tuebingen, Germany