Evaluation of Low-thermal Argon Plasma Devitalization (LtAPD) for the Treatment of Cervical Intraepithelial Neoplasia (CIN) Grade 2 Versus Standard of Active Surveillance
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 264
- Locations
- 1
- Primary Endpoint
- Histopathological remission of CIN 2
Study Overview
Brief Summary
The study aims to show that treatment with LtAPD works better than a sham treatment or simply monitoring the condition closely without active treatment ("active surveillance"), in achieving complete healing of a tissue abnormality on the cervix called CIN 2, after 6 months. This will be confirmed by examining tissue samples under a microscope (histopathological examination).
Detailed Description
Participation in the study lasts 6 months. Eligible participants are randomly assigned to one of two groups: participants receiving LtAPD treatment (treatment group) or participants receiving a sham procedure, in which LtAPD treatment is simulated but not actually applied (control group). All participants continue to be managed according to the current standard of care, active surveillance with regular monitoring, throughout the study. Participants remain blinded to their treatment assignment. The study includes four visits.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female sex
- •Age 18 - 40 years at the time of signing the informed consent
- •Histologically confirmed CIN 2
- •Full visibility of the entire transformation zone (Type 1 or Type 2) and entire lesion in colposcopy
- •Ability to understand the nature of the clinical investigation and voluntarily signs the informed consent document prior to any study-related procedures
Exclusion Criteria
- •Histologically confirmed CIN other than CIN 2, or indication of (micro-) invasive cervical disease
- •CIN lesions extending to the vaginal vault or suspicion of endocervical disease
- •Current pregnancy or planned pregnancy within the next 6 months
- •Presence of severe local inflammation or active infection
- •Presence of a severe cardiovascular, neurological, psychiatric, endocrine, or hematological disease, immunocompromised condition or malignant tumor of any origin, as judged by the investigator
- •Participation in an interfering clinical study, as judged by the investigator
Arms & Interventions
LtAPD
Treatment with low-thermal argon plasma devitalization
Intervention: Treatment with low-thermal argon plasma devitalization (Device)
Sham
Sham treatment
Intervention: Sham treatment (Device)
Outcomes
Primary Outcomes
Histopathological remission of CIN 2
Time Frame: at 6 months
Percentage of patients with histopathologically confirmed remission of CIN 2 (absence of CIN 2 or higher grade lesion), assessed by cervical biopsy/histopathological evaluation
Secondary Outcomes
- HPV remission rate(at 6 months)
- Cytological remission of CIN(at 6 months)
- Quality of life, comfort/ discomfort of the treatment procedure and sexual activity(at baseline, intervention, 6 months)
- Correlation of electrosurgical unit (ESU) and video data with CIN remission and applied argon plasma(at 6 months)