Clinical trial · Interventional
Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia
NCT03218436CI-TRIAL-00079053CAPCINcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Cervical intraepithelial neoplasia will be treated with physical low temperature plasma in the plasma cohort compared to watchful waiting in the control cohort. Primary endpoint after 3-6 months: Pathological remission. Secondary endpoint: HPV remission.
Conditions
Conditions (1)
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 | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAP treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CAP cohort
- description
- Cold Atmospheric plasma intervention
- interventionNames
- Procedure: CAP treatment
- type
- NO_INTERVENTION
- label
- Control cohort
- description
- no intervention
Primary outcomes (1)
- measure
- Pathological remission of cervical intraepithelial neoplasia
- timeFrame
- 3-6 months
- description
- Biopsy, Histopathological examination
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for CAP: * Histologically confirmed CIN I / II * Reliable assessment of the radius of the portio and marginal borders of the lesions * Written consent for treatment with low temperature plasma after reconnaissance Inclusion Criteria for Control-Group: * Histologically confirmed CIN I / II * Reliable assessment of the radius of the portio and marginal borders of the lesions * Patients who want a waiting procedure and a control examination after 3-6 months Exclusion Criteria: * Histologically confirmed CIN III * Not fully visible transformation zone * An indication of invasive disease * Expected lack of compliance of the patient or incapacity of the patient to understand the meaning and purpose of the clinical trial * Severe cardio-vascular disease * Lack of patient consent
References
Publications (1)
- DERIVEDWeiss M, Arnholdt M, Hissnauer A, Fischer I, Schonfisch B, Andress J, Gerstner S, Dannehl D, Bosmuller H, Staebler A, Brucker SY, Henes M. Tissue-preserving treatment with non-invasive physical plasma of cervical intraepithelial neoplasia-a prospective controlled clinical trial. Front Med (Lausanne). 2023 Aug 15;10:1242732. doi: 10.3389/fmed.2023.1242732. eCollection 2023. PMID 37654659