EUCTR2020-001342-19-NL进行中（未招募）1 期
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)
Asieris MediTech Co., Ltd.0 个研究点目标入组 384 人开始时间: 2021年10月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 384
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
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