The study aims to show that treatment with LtAPD works better than a sham treatment or simply monitoring the condition closely without active treatment ("active surveillance"), in achieving complete healing of a tissue abnormality on the cervix called CIN 2, after 6 months. This will be confirmed by examining tissue samples under a microscope (histopathological examination).
Female sex
Age 18 - 40 years at the time of signing the informed consent
Histologically confirmed CIN 2
Full visibility of the entire transformation zone (Type 1 or Type 2) and entire lesion in colposcopy
Histologically confirmed CIN other than CIN 2, or indication of (micro-) invasive cervical disease
CIN lesions extending to the vaginal vault or suspicion of endocervical disease
Current pregnancy or planned pregnancy within the next 6 months
Presence of severe local inflammation or active infection
Parallel
Treatment with low-thermal argon plasma devitalization
DeviceSingle session of LtAPD treatment applied to the CIN2 lesion under colposcopic guidance; outpatient, no anesthesia required.
Sham treatment
DeviceSingle session of sham treatment (no argon gas delivery and plasma ignition; acoustic signal to maintain blinding) followed by active surveillance according to current clinical guidelines.
Histopathological remission of CIN 2
Percentage of patients with histopathologically confirmed remission of CIN 2 (absence of CIN 2 or higher grade lesion), assessed by cervical biopsy/histopathological evaluation
HPV remission rate
Percentage of patients with HPV remission, assessed by validated HPV testing and p16 immunohistochemistry
Cytological remission of CIN
Percentage of patients with cytological remission, assessed by Papanicolaou (PAP) smear according to the Bethesda classification system
Quality of life, comfort/ discomfort of the treatment procedure and sexual activity
Change from baseline in quality of life and sexual health at baseline and 6 months, assessed by the Freiburg Index of Patient Satisfaction (FIPS) and the Sexual Activity Questionnaire (SAQ)
Correlation of electrosurgical unit (ESU) and video data with CIN remission and applied argon plasma
assessed by correlation of ESU and video data with CIN remission and applied argon plasma
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