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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorUniversity Hospital Tuebingen

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Treatment with low-thermal argon plasma devitalization
  • Sham treatment

Treatment groups

264 Participants
are divided into 2 treatment groups

Sponsors and collaborators