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).
Participation in the study lasts 6 months. Eligible participants are randomly assigned to one of two groups: participants receiving LtAPD treatment (treatment group) or participants receiving a sham procedure, in which LtAPD treatment is simulated but not actually applied (control group). All participants continue to be managed according to the current standard of care, active surveillance with regular monitoring, throughout the study. Participants remain blinded to their treatment assignment. The study includes four visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
264
Single session of LtAPD treatment applied to the CIN2 lesion under colposcopic guidance; outpatient, no anesthesia required.
Single 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.
University Hospital Tuebingen, Department of Women's Health
Tübingen, Baden-Wurttemberg, Germany
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
Time frame: at 6 months
HPV remission rate
Percentage of patients with HPV remission, assessed by validated HPV testing and p16 immunohistochemistry
Time frame: at 6 months
Cytological remission of CIN
Percentage of patients with cytological remission, assessed by Papanicolaou (PAP) smear according to the Bethesda classification system
Time frame: at 6 months
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)
Time frame: at baseline, intervention, 6 months
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
Time frame: at 6 months
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