Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia
NCT ID: NCT03218436
Last Updated: 2024-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2017-09-01
2022-03-31
Brief Summary
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Primary endpoint after 3-6 months: Pathological remission.
Secondary endpoint: HPV remission.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CAP cohort
Cold Atmospheric plasma intervention
CAP treatment
Treatment with low-temperature argon plasma during colposcopic examination. No general anesthesia required.
Control cohort
no intervention
No interventions assigned to this group
Interventions
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CAP treatment
Treatment with low-temperature argon plasma during colposcopic examination. No general anesthesia required.
Eligibility Criteria
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Inclusion Criteria
* Reliable assessment of the radius of the portio and marginal borders of the lesions
* Written consent for treatment with low temperature plasma after reconnaissance
* 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
* 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
18 Years
FEMALE
No
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Principal Investigators
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Melanie Henes, Dr.
Role: PRINCIPAL_INVESTIGATOR
Department for Women's Health
Martin Weiss, Dr.
Role: PRINCIPAL_INVESTIGATOR
Department for Women's Health
Locations
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Department for Women's Health
Tübingen, , Germany
Countries
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References
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Weiss 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.
Related Links
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doi: 10.3389/fmed.2023.1242732
Other Identifiers
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CAP CIN
Identifier Type: -
Identifier Source: org_study_id
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