Study of Real-world Evidence in Patients Treated With Cerviron Vaginal Ovules in the Treatment of Cervical Lesions of Various Etiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 345
- 试验地点
- 15
- 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
The aim of the study was to assess the post-market performance and tolerability of Cerviron® ovules in the treatment and management of cervical lesions of different etiologies. The study included clinical data related to aspect of lesions performed during routine colposcopy exams, the degree of re-epithelialization of the cervical mucosa, vaginal pH, pain level, and vaginal bleeding level.
详细描述
This study is an observational, post-marketing study conducted between May-July 2021.
The aim of the study was to assess the post-market performance and tolerability of Cerviron® ovules in the treatment and management of cervical lesions of different etiologies.
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.
The study population included 345 participants aged 20-70 years with either a cervical lesion under treatment or with recent surgical removal of a cervical lesion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with a clearly diagnosed non-infectious gynecological disease and patients with traumatic or surgical lesions.
- •Patients with either of the following medical history: trauma of the cervix, pain, bleeding after sexual intercourse, postpartum injuries or postoperative cervical lesions.
排除标准
- •Patients with cervical cancer.
- •Patients with vulvar cancer
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 of participants with treatment-related adverse events as assessed by CTCAE v5.0
次要结局
- Clinical Performance assessed by the investigator(3 months)
- Patient Satisfaction(3 months)