Efficacy and Safety of Cevira® in Patients With Cervical Histologic High-grade Squamous Intraepit… (NCT04484415) | Clinical Trial Compass
UnknownPhase 3
Efficacy and Safety of Cevira® in Patients With Cervical Histologic High-grade Squamous Intraepithelial Lesions (HSIL)
China402 participantsStarted 2020-11-10
Plain-language summary
A double blind, prospective, randomized, placebo controlled, multi-center phase 3 study to evaluate efficacy and safety of Cevira® in patients with cervical histologic high-grade squamous intraepithelial lesions (HSIL).
Who can participate
Age range18 Years – 85 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Biopsy-confirmed HSIL histology determined by a panel of 3 pathologists from a central laboratory in each region (China, US, and Europe);
✓. Adequate colposcopy including:
✓. visualization of entire cervical transformation zone including the squamocolumnar junction
✓. visualization of entire lesion margin
✓. Colposcopically visible lesion after biopsy, before treatment (Note: To ensure a colposcopically visible lesion after biopsy, the lesion should cover approximately 15% of the uterine cervix before biopsy)
✓. Average sized uterine cervix suitable for application of the Cevira® device
✓. Use of adequate birth control until completion of the 6 month assessment visit
✓. Age 18 or older (Note: Patients aged 18-20 should not be actively recruited)
Exclusion criteria
✕. Biopsy-confirmed HSIL (CIN3) histology with a total lesion area covering more than half of the uterine cervix area
✕. Invasive cervical cancer
✕. Adenocarcinoma in situ, or other glandular intraepithelial lesions
✕. Lesion(s) extending to the cervical canal (as clinically indicated and whether to perform endocervical curettage \[ECC\] test at the discretion of the investigators)
What they're measuring
1
The proportion of responders at 6 months after first treatment