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NCT07730645
Evaluation of Low-thermal Argon Plasma Devitalization for the Treatment of CIN 2 Versus Standard of Active Surveillance
Conditions: Cervical Intraepithelial Neoplasia Grade 2 (CIN2), Cervical Intraepithelial Neoplasia Grade 2, CIN2
Sex: Female
Ages: 18 Years – 40 Years
Healthy volunteers: No
Phase: NA
Enrollment: 264
Sponsor: University Hospital Tuebingen
Location: University Hospital Tuebingen, Department of Women's Health Tübingen Baden-Wurttemberg
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 Criteria
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
Source: ClinicalTrials.gov (NCT07730645). StuddyBuddy aggregates publicly available trial information.