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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06291311
• Other study ID #: MT_NIPP-HPV_ERBE
• Status: Recruiting
• Start date: December 27, 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: University Hospital Tuebingen
• Contact: Martin Weiss, Dr. med.
• Phone: +497071 29 82211
• Email: martin.weiss[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Communicable Diseases
• HPV Infection
• Infections
• Papillomavirus Infections

Intervention

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
A potential natural healing of the HPV infection will be anticipated

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen, Department of Women's Health	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV eradication rate	In the following intervention study, participants will be tested for HPV infection before and after NIPP treatment.	3-6 months
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)