Clinical trial · Interventional
Treatment of Cervical Intraepithelial Neoplasia (CIN) Grade III With Non-invasive Physical Plasma
- 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 aim of the prospective, unicenter proof-of-principle study is to investigate the anti-neoplastic effectiveness of NIPP against CIN III lesions. * The aim of this project is to evaluate the potential of a previous NIPP treatment to significantly reduce the invasiveness of the LEEP excision. * Another aim of this study is to investigate cellular / molecular effects of NIPP following the in-vivo treatment of the cervix using molecular biological methods. For this purpose, tissue treated with plasma is taken after defined periods of time by mini biopsy and examined using molecular biological, histological and microscopic methods.
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 III | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-invasive physical plasma | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NIPP
- description
- Treatment of the NIPP group with physical low-temperature plasma, subsequently within 8 weeks LEEP-Exzision
- interventionNames
- Procedure: Non-invasive physical plasma
- type
- NO_INTERVENTION
- label
- Controll
- description
- LEEP-Exzision
Primary outcomes (1)
- measure
- Rate of histological complete remission
- timeFrame
- 8 Weeks
- description
- Rate of histological complete remission of the CIN III at the time of the LEEP excision
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Histologically confirmed CIN III * Clearly visible transformation zone of the portio and margins of the lesions according to T1 / T2 * signed written consent Exclusion Criteria: * Not fully visible transformation zone * Indication of an invasive disease * Serious cardiovascular diseases * Patients who only want to undergo a LEEP excision
References
Publications (1)
- DERIVEDHenes M, Matovina S, Rottscholl R, Feng YS, Fleischhacker A, Wang G, Enderle M, Awakowicz P, Brucker SY, Weiss M. Tissue preserving non-invasive physical plasma treatment for cervical squamous intraepithelial neoplasia grade 3-a prospective randomized, controlled clinical trial. Front Med (Lausanne). 2025 Nov 7;12:1669933. doi: 10.3389/fmed.2025.1669933. eCollection 2025. PMID 41282018