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Recruiting NCT06291311

NCT06291311 Non-Invasive Plasma Treatment for Cervical Infections: Targeting High- and Low-Risk HPV Variants

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Clinical Trial Summary
NCT ID NCT06291311
Status Recruiting
Phase
Sponsor University Hospital Tuebingen
Condition HPV Infection
Study Type OBSERVATIONAL
Enrollment 50 participants
Start Date 2023-12-27
Primary Completion 2026-09

Trial Parameters

Condition HPV Infection
Sponsor University Hospital Tuebingen
Study Type OBSERVATIONAL
Phase N/A
Enrollment 50
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2023-12-27
Completion 2026-09
Interventions
Cold physical PlasmaControl group

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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.

Eligibility Criteria

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

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