Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia (CAPCIN)
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|ClinicalTrials.gov Identifier: NCT03218436|
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : February 7, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Intraepithelial Neoplasia||Procedure: CAP treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia|
|Actual Study Start Date :||August 31, 2017|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||July 1, 2020|
Active Comparator: CAP cohort
Cold Atmospheric plasma intervention
Procedure: CAP treatment
Treatment with low-temperature argon plasma during colposcopic examination. No general anesthesia required.
No Intervention: Control cohort
- Pathological remission of cervical intraepithelial neoplasia [ Time Frame: 3-6 months ]Biopsy, Histopathological examination
- Human papilloma virus remission rate [ Time Frame: 3-6 months ]Smear testing
- Comfort / Dyscomfort during intervention [ Time Frame: Immediately, 2 week, 3-6 months ]Freiburger Index of patient comfort
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218436
|Contact: Melanie Henes, Dr.||+49 email@example.com|
|Contact: Martin Weiss, Dr.||+49 firstname.lastname@example.org|
|Department for Women's Health||Recruiting|
|Tübingen, Germany, 72076|
|Contact: Miriam Linneweh, Dr 004970712985380 email@example.com|
|Principal Investigator:||Melanie Henes, Dr.||Department for Women's Health|
|Principal Investigator:||Martin Weiss, Dr.||Department for Women's Health|