Overview
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).
Description
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.
Eligibility
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
