Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia (CAPCIN)

University Hospital Tuebingen

Status

Completed

Conditions

Cervical Intraepithelial Neoplasia

Treatments

Procedure: CAP treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03218436

CAP CIN

Details and patient eligibility

About

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.

Full 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.

Enrollment

63 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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