Treatment with low-thermal argon plasma devitalizationSham treatment
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.
Study 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).
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
* Ability to understand the nature of the clinical investigation and voluntarily signs the informed consent document prior to any study-related procedures
Exclusion Criteria:
* 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
* Presence of a severe cardiovascular, neurological, psychiatric, endocrine, or hematological disease, immunocompromised condition or malignant tumor of any origin, as judged by the investigator
* Participation in an interfering clinical study, as judged by the investigator
Primary outcome measure(s)
Histopathological remission of CIN 2 — at 6 months Percentage of patients with histopathologically confirmed remission of CIN 2 (absence of CIN 2 or higher grade lesion), assessed by cervical biopsy/histopathological evaluation
Trial sites (1)
Facility
City
Region
Status
University Hospital Tuebingen, Department of Women's Health
Tübingen
Baden-Wurttemberg
More University Hospital Tuebingen trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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