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

Not Yet RecruitingNA

Sponsor: University Hospital Tuebingen

Conditions: Cervical Intraepithelial Neoplasia Grade 2 (CIN2), Cervical Intraepithelial Neoplasia Grade 2, CIN2

Interventions: Treatment with low-thermal argon plasma devitalization, Sham treatment

Countries: Germany

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 overview

Sex: FEMALE

Age: 18 Years to 40 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Tübingen, Baden-Wurttemberg, Germany