NL-OMON50923已完成3 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) - YHGT-CEV-R1
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Biopsy-confirmed HSIL histology determined by a panel of 3 pathologists from
- •a central laboratory in 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 (approximately 27 mm in diameter) 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
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. Patients who previously received surgical treatment, have incomplete
- •cervical structure and have recurrent HSIL; or patients who received other
- •treatment after the confirmed diagnosis of HSIL
- •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, and other electronic implants
- •17. Use of any mechanical barriers such as the contraceptive FemCap
- •18. Inappropriate anatomical and physiological conditions (natural or acquired
- •through disease) such as metrorrhagia and causes (myoma, endometrial carcinoma,
- •polyposis, etc.), uterine/cervical prolapse, vaginal dryness, period of the
- •woman's menstruation and other
- •19. Participation in other therapeutic clinical trials using investigational
- •agents either concurrently or within the last 30 days
- •20. Patients that in the investigator*s opinion are not suitable for
- •participation
- •21. 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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