Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia
Not Applicable
Completed
- Conditions
- Cervical Intraepithelial Neoplasia
- Interventions
- Procedure: CAP treatment
- Registration Number
- NCT03218436
- Lead Sponsor
- University Hospital Tuebingen
- 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.
- Detailed Description
The study was completed with Less recruitment as it was planned due to overwhelming study success. The study was published in August 2023. A link has been added to the Reference section.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 63
Inclusion Criteria
Not provided
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CAP cohort CAP treatment Cold Atmospheric plasma intervention
- Primary Outcome Measures
Name Time Method Pathological remission of cervical intraepithelial neoplasia 3-6 months Biopsy, Histopathological examination
- Secondary Outcome Measures
Name Time Method Human papilloma virus remission rate 3-6 months Smear testing
Comfort / Dyscomfort during intervention Immediately, 2 week, 3-6 months Freiburger Index of patient comfort
Trial Locations
- Locations (1)
Department for Women's Health
🇩🇪Tübingen, Germany