A Phase 3 study to evaluate efficacy and safety of Cevira® in patients with cervical histologic high-grade squamous intraepithelial lesions
- Conditions
- Patients with cervical histologic HSIL.MedDRA version: 21.0Level: LLTClassification code 10064455Term: HSILSystem Organ Class: 100000004872Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2020-001342-19-PL
- Lead Sponsor
- Asieris MediTech Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 384
1.Biopsy-confirmed HSIL histology determined by a panel of three
pathologists from at the central laboratory in of each region (China, US, and Europe);
2. Adequate colposcopy including:
a. visualization of entire cervical transformation zone including the squamocolumnar junction
b. visualization of entire lesion margin
3. 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)
4. Average sized uterine cervix suitable for application of the Cevira® device
5. Female (not breastfeeding, with negative pregnancy test and using either a highly effective method of contraception during the entire study and 30 days after end of the study or being post-menopausal for at least 1 year or sterilized women)
6. Age 18 or older (Note: Patients aged 18-20 should not be actively recruited)
7. Signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 288
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 96
1. Biopsy-confirmed HSIL (CIN3) histology with a total lesion area covering more than half of
the uterine cervix area
2. Invasive cervical cancer
3. Adenocarcinoma in situ, or other glandular intraepithelial lesions
4. Lesion(s) extending to the cervical canal (as clinically indicated and whether to perform
endocervical curettage [ECC] test at the discretion of the investigators)
5. Lesion(s) extending to the vaginal vault
6. Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynecological
infection as per colposcopy and clinical examination
7. Vaginal bleeding at time of treatment at the discretion of the investigator
8. Pregnancy
9. Nursing
10. Childbirth or miscarriage within six weeks of enrolment
11. Previous treatment of cervical intraepithelial lesions (CIN) or cervical invasive disease
12. History of toxic shock syndrome
13. Known or suspected porphyria
14. Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or
aminolevulinic acid)
15. Known allergy to silicone
16. Use of heart pacemaker
17. Participation in other therapeutic clinical trials using investigational agents either
concurrently or within the last 30 days
18. Patients that in the investigator’s opinion are not suitable for participation
19. Patient is the investigator or any sub-investigator, research assistant, pharmacist, study
coordinator, other staff or relative thereof directly involved in the conduct of the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method