A Prospective, Open-Label, Pilot, Multicentric Clinical Investigation to Evaluate the Performance and Safety of Cerviron® Ovules in Cervix Lesions Postoperative Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 5
- 主要终点
- Rate of treatment-related Adverse Events in subjects participating in the clinical investigation
研究概览
简要总结
CYRON is a Prospective, Open-Label, Pilot, Multicentric Clinical Investigation to Evaluate the Performance and Safety of Cerviron® Ovules in Cervix Lesions Postoperative Care. The primary objective is to assess the therapeutic performance and tolerability of Cerviron® Ovules in postoperative care in patients that underwent surgical removal of benign, cervical lesions. The secondary objective of this clinical investigation is the assessment of performance of the medical device by clinical exam and patients' degree of satisfaction related to the use of the medical device.
详细描述
Identifying premalignant and benign diseases of the cervix and selecting an appropriate treatment path can be challenging. The adult uterine cervix may exhibit a wide variety of pathologic conditions that include benign entities (eg, cervicitis, hyperplasia, nabothian cysts, cervical polyps, leiomyomas, endometriosis, and congenital abnormalities) as well as malignant lesions, particularly cervical carcinoma.
Cervical lesions range from being visible only with an instrument that augments sight such as a colposcope to being visible by speculum examination or endovaginal ultrasound.
The most frequent types of cervical lesions are:
1. Cervical polyp Cervical polyps are benign growths, usually protruding from the surface of the cervical canal. They commonly occur during the reproductive years, especially in women over 20 years of age. Cervical polyps are the most common non-cancerous tumour of the cervix.
The cervical polyps may vary in size, shape, and origin. They can present as single or multiple, tear-shaped or lobular, cherry-red, or greyish-white in color, depending on the vascularity of the lesion. The size of the cervical polyp is typically less than three cm in diameter; however, as mentioned earlier, they can vary in size and can be large enough to fill the vagina or be present at the introitus They usually originate in the endocervical canal. Endocervical polyps may be caused by chronic inflammation. They rarely become malignant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult females, aged 18 years to 65 years;
- •Subjects presenting benign, ectopic, cervix lesions that were excised no later than 7 days before the Screening Visit, confirmed by colposcopy;
- •Subjects presenting a normal cervical cytology report, e.g. Negative for Intraepithelial Lesions or Malignancy (NILM) or slightly modified to Atypical Squamous Cells of Undetermined Significance (ASC-US) in the last 6 months;
- •Subjects willing to provide signed informed consent to clinical investigation participation.
排除标准
- •Previous history of any malignancy, particularly those that are prone to metastases, including breast, melanoma, gestational trophoblastic disease, and high-grade malignancies of the gastrointestinal tract or lung;
- •Subjects with undiagnosed abnormal genital bleeding;
- •Subject with vulvar, vaginal or cervical cancer;
- •Subjects presenting an abnormal cytology report, e.g. cervical intraepithelial neoplasia" (CIN) or "adenocarcinoma in situ" (AIS) in the last 6 months;
- •Watery or foul discharge;
- •Subjects with HIV or other immunodeficiency;
- •Use of spermicides;
- •Use of diaphragm;
- •Concomitant topical or systemic anti-infective treatment;
- •Unable to comply with visit procedures;
- •Subjects included in other clinical investigations with similar objectives
结局指标
主要结局
Rate of treatment-related Adverse Events in subjects participating in the clinical investigation
时间窗: 3 months
Number and degree of AE
Clinical Performance Assessed by the Investigator by Colposcopy at End of Treatment Visit
时间窗: 3 months
Evolution of cervical lesions at End of Treatment Visit
次要结局
- Patient Satisfaction (Likert Scale)(3 months)
- Evolution of vaginal symptoms and discomfort(at 1, 2 and 3 months)
- The Re-epithelialization degree of the cervical mucosa by thorough gynaecological examination (visual evaluation)(at 1, 2 and 3 months)