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NCT03218436 Clinical Trial

Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia

Cervical Intraepithelial Neoplasia Clinical Trial

— CAPCIN  

Official title:
Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03218436
Other study ID # CAP CIN
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 31, 2017
Est. completion date July 1, 2021

Study information
Verified date February 2020
Source University Women's Hospital Tübingen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 170
Est. completion date July 1, 2021
Est. primary completion date November 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• CAP treatment
Treatment with low-temperature argon plasma during colposcopic examination. No general anesthesia required.

Locations
Country Name City State
Germany Department for Women's Health Tübingen

Sponsors (1)
Lead Sponsor Collaborator
University Women's Hospital Tübingen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pathological remission of cervical intraepithelial neoplasia Biopsy, Histopathological examination 3-6 months
Secondary Human papilloma virus remission rate Smear testing 3-6 months
Secondary Comfort / Dyscomfort during intervention Freiburger Index of patient comfort Immediately, 2 week, 3-6 months
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