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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer; HPV Infection
• Intervention / Treatment: Other: Cold physical Plasma; Other: Control group

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Martin Weiss, Dr. med.; Phone Number: +497071 29 82211; Email: martin.weiss@med.uni-tuebingen.de

Study Locations

• Germany
  • Tübingen, Germany, 72076
    • Recruiting
    • University Hospital Tuebingen, Department of Women's Health
    • Contact: Martin Weiss, Dr. med.; Phone Number: +4970712982211; Email: martin.weiss@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NIPP treatment; Treatment with cold physical Plasma	Other: 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.
Control group; No treatment with cold physical Plasma	Other: Control group; A potential natural healing of the HPV infection will be anticipated

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	During the study (12-24 months)

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Martin Weiss, Dr. med., University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Infections; Virus Diseases; Uterine Diseases; Genital Diseases, Female; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Tumor Virus Infections; Pathological Conditions, Signs and Symptoms; Uterine Cervical Neoplasms; Papillomavirus Infections; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: MolGyn_NIPP-HPV_ERBE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No