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Evaluation of Low-thermal Argon Plasma Devitalization for the Treatment of CIN 2 Versus Standard of Active Surveillance
Sponsor: University Hospital Tuebingen
Summary
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).
Official title: Evaluation of Low-thermal Argon Plasma Devitalization (LtAPD) for the Treatment of Cervical Intraepithelial Neoplasia (CIN) Grade 2 Versus Standard of Active Surveillance
Key Details
Gender
FEMALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
264
Start Date
2026-09-24
Completion Date
2029-09-30
Last Updated
2026-10-01
Healthy Volunteers
No
Conditions
Interventions
Treatment with low-thermal argon plasma devitalization
Single session of LtAPD treatment applied to the CIN2 lesion under colposcopic guidance; outpatient, no anesthesia required.
Sham treatment
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.
Locations (1)
University Hospital Tuebingen, Department of Women's Health
Tübingen, Baden-Wurttemberg, Germany