Biop System's Safety and Performance in Increased Detection of High-grade Lesions of the Cervical Epithelium in Women Scheduled for Colposcopy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 320
- 主要终点
- SAE
研究概览
简要总结
Biop system's safety and performance in increased detection of High-Grade lesions of the cervical epithelium in women scheduled for colposcopy
详细描述
Biop system's safety and performance in increased detection of high-grade lesions of the cervical epithelium in women scheduled for colposcopy.
This is a multi-center, prospective, open label, non-randomized study to train the Biop System's algorithm and evaluate the safety and performance of the Biop system in women undergoing cervical colposcopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female Age ≥ 22 years and ≤
- •Referred for colposcopy, following abnormal cervical cytology;
- •Participant provides signed informed consent
排除标准
- •Currently pregnant (through six weeks postpartum) or nursing
- •Currently menstruating
- •Previous hysterectomy
- •Currently has intrauterine device (IUD)
- •Cervical biopsy or therapeutic procedure since the referral cervical cytology,
- •Diagnosed with diseases that may influence the color of the tissue, e.g., hepatitis, polycythemia vera.
- •Known human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS) (Applicable to training stage only)
- •A known latex allergy
- •Psychological instability, inappropriate attitude or motivation
- •Cervical cytology tests within the prior seven days
- •Use of vaginal medications within the last 48 h or photosensitizing agents within 72 h
- •History of photosensitivity or other diseases affected by UV radiation,
- •An observable and untreated gynecological infection.
- •Previous history of CIN therapy
研究组 & 干预措施
Bןםפ Sטדאקצ
Biop Colposcopy procedure
干预措施: Biop System (Device)
结局指标
主要结局
SAE
时间窗: through study completion, an average of 1 year
The primary safety endpoint will be consisted of frequency and incidence of all Device Related Adverse Events (AE) and Serious Adverse Events (SAE).
Performance
时间窗: through study completion, an average of 1 year
Incremental True positive (TP) rate and Incremental False positive (FP) rate
次要结局
未报告次要终点