Cervical Intraepithelial Neoplasia
Conditions
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.
Interventions
PROCEDURECAP treatment
Treatment with low-temperature argon plasma during colposcopic examination. No general anesthesia required.
Sponsors
University Hospital Tuebingen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological remission of cervical intraepithelial neoplasia | 3-6 months | Biopsy, Histopathological examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed