Low-thermal Argon Plasma Devitalization for CIN2 Treatment
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
Run by University Hospital Tuebingen · NCT07730645 · Data updated 2026-11-12
This study tests whether a low-thermal argon plasma treatment can heal CIN2 on the cervix better than a sham procedure or active surveillance in women aged 18–40.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 264 (estimated) |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen, Baden-Wurttemberg) |
| Status | Recruiting |
| Started | September 24, 2026 |
| Main results expected | March 31, 2029 |
| Study ends | September 30, 2029 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT07730645 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–40 with histologically confirmed CIN2 and fully visible transformation zone on colposcopy.
✕Probably not a fit
Participants with CIN2 that does not respond to LtAPD or who are assigned to sham may not experience disease resolution.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares LtAPD, a low-thermal argon plasma treatment, to a sham procedure in women with CIN2 over six months. Participants are randomly assigned to either treatment or sham and remain blinded to their group while standard care with active surveillance continues. Histopathology at six months confirms whether CIN2 has fully resolved. The study includes four visits and follows current clinical management guidelines throughout participation. Eligibility focuses on histologically confirmed CIN2 with fully visible cervical transformation zone, and excludes pregnancy, other CIN grades, and certain health conditions.
Why it matters
Potential benefit: If successful, LtAPD could increase the chance of complete CIN2 resolution and reduce the need for more invasive treatment.
How similar studies have gone: Prior similar approaches have shown promise in pilot contexts, but this exact LtAPD strategy for CIN2 is investigational.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University Hospital Tuebingen, Department of Women's Health
Tübingen, Baden-Wurttemberg, Germany Recruiting
Study contacts
- Principal investigator: Felix Neis, PD Dr. — University Hospital Tuebingen, Department of Women's Health, Tübingen
- Study coordinator: Martin Weiss, Prof. Dr.
- Email: martin.weiss@med.uni-tuebingen.de
- Phone: +49 7071 29 82211
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.