Evaluation of Low-thermal Argon Plasma Devitalization for the Treatment of CIN 2 Versus Standard of Active Surveillance | NCT07730645

NCT07730645

Overview

NCT ID: NCT07730645
Lead Sponsor: University Hospital TuebingenOTHER
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
Brief 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).
Conditions: Cervical Intraepithelial Neoplasia Grade 2 (CIN2)
Cervical Intraepithelial Neoplasia Grade 2
CIN2

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
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

Central Contacts: Martin Weiss, Prof. Dr.Contact
martin.weiss@med.uni-tuebingen.de+49 7071 29 82211