Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia

University Hospital Tuebingen63 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervical Intraepithelial Neoplasia

Interventions

CAP treatmentPROCEDURE

Treatment with low-temperature argon plasma during colposcopic examination. No general anesthesia required.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department for Women's Health

Tübingen, Germany

Outcomes

Primary Outcomes

Pathological remission of cervical intraepithelial neoplasia

Biopsy, Histopathological examination

Time frame: 3-6 months

Secondary Outcomes

Human papilloma virus remission rate

Smear testing

Time frame: 3-6 months

Comfort / Dyscomfort during intervention

Freiburger Index of patient comfort

Time frame: Immediately, 2 week, 3-6 months

Data from ClinicalTrials.gov

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