Cervical Intraepithelial Neoplasia Grade 2, Cervical Intraepithelial Neoplasia Grade 2 (CIN2), CIN2
Conditions
Keywords
CIN2, Cervical Intraepithelial Neoplasia Grade 2, Low-thermal argon plasma devitalization, LtAPD, Plasma application, Plasma treatment, Physical plasma, Physical plasma treatment
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.
Interventions
DEVICETreatment with low-thermal argon plasma devitalization
Single session of LtAPD treatment applied to the CIN2 lesion under colposcopic guidance; outpatient, no anesthesia required.
DEVICESham treatment
Single session of sham treatment (no argon gas delivery and plasma ignition; acoustic signal to maintain blinding) followed by active surveillance according to current clinical guidelines.
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histopathological remission of CIN 2 | 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
| Measure | Time frame | Description |
|---|---|---|
| HPV remission rate | at 6 months | Percentage of patients with HPV remission, assessed by validated HPV testing and p16 immunohistochemistry |
| Cytological remission of CIN | at 6 months | Percentage of patients with cytological remission, assessed by Papanicolaou (PAP) smear according to the Bethesda classification system |
| Quality of life, comfort/ discomfort of the treatment procedure and sexual activity | at baseline, intervention, 6 months | Change from baseline in quality of life and sexual health at baseline and 6 months, assessed by the Freiburg Index of Patient Satisfaction (FIPS) and the Sexual Activity Questionnaire (SAQ) |
| Correlation of electrosurgical unit (ESU) and video data with CIN remission and applied argon plasma | at 6 months | assessed by correlation of ESU and video data with CIN remission and applied argon plasma |
Countries
Germany
Contacts
CONTACTMartin Weiss, Prof. Dr.
PRINCIPAL_INVESTIGATORFelix Neis, PD Dr.
University Hospital Tuebingen, Department of Women's Health, Tübingen
Outcome results
None listed