Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia
CAPCIN
1 other identifier
interventional
63
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2017
CompletedFirst Posted
Study publicly available on registry
July 14, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedJuly 23, 2024
July 1, 2024
4.6 years
July 13, 2017
July 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Pathological remission of cervical intraepithelial neoplasia
Biopsy, Histopathological examination
3-6 months
Secondary Outcomes (2)
Human papilloma virus remission rate
3-6 months
Comfort / Dyscomfort during intervention
Immediately, 2 week, 3-6 months
Study Arms (2)
CAP cohort
ACTIVE COMPARATORCold Atmospheric plasma intervention
Control cohort
NO INTERVENTIONno intervention
Interventions
Treatment with low-temperature argon plasma during colposcopic examination. No general anesthesia required.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department for Women's Health
Tübingen, 72076, Germany
Related Publications (1)
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.
PMID: 37654659DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melanie Henes, Dr.
Department for Women's Health
- PRINCIPAL INVESTIGATOR
Martin Weiss, Dr.
Department for Women's Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2017
First Posted
July 14, 2017
Study Start
September 1, 2017
Primary Completion
March 31, 2022
Study Completion
March 31, 2022
Last Updated
July 23, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share