Clinical trial · Interventional
Evaluation of Low-thermal Argon Plasma Devitalization for the Treatment of CIN 2 Versus Standard of Active Surveillance
Evaluation of Low-thermal Argon Plasma Devitalization (LtAPD) for the Treatment of Cervical Intraepithelial Neoplasia (CIN) Grade 2 Versus Standard of Active Surveillance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia Grade 2 | — | UNRESOLVED | — |
| Cervical Intraepithelial Neoplasia Grade 2 (CIN2) | — | UNRESOLVED | — |
| CIN2 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sham treatment | Device | — | UNRESOLVED |
| Treatment with low-thermal argon plasma devitalization | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LtAPD
- description
- Treatment with low-thermal argon plasma devitalization
- interventionNames
- Device: Treatment with low-thermal argon plasma devitalization
- type
- SHAM_COMPARATOR
- label
- Sham
- description
- Sham treatment
- interventionNames
- Device: Sham treatment
Primary outcomes (1)
- measure
- Histopathological remission of CIN 2
- timeFrame
- at 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available