A Study to Evaluate the Effectiveness of the Rover Cervex-Brush Device vs. the Personal Pap Smear Device™ for Collection of Cervical Cells for Detecting Cervical Dysplasia or Neoplasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Comparison of the samples for the Predicate Device versus PPS device
研究概览
简要总结
This purpose of this research study is to determine the effectiveness of the Personal Pap Smear Device™ to collect adequate cervical cell samples for cytology examination when compared with the Rover Cervex-Brush (Cervix-Examination Brush).
详细描述
To determine the effectiveness of the Personal Pap Smear Device™ to collect adequate (as defined by Bethesda Guidelines 2014) cervical cell samples for cytology examination as compared with the Rover Cervex-Brush (Cervix-Examination Brush).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult women, aged 21-65 years old.
- •Do not have any medical or psychiatric condition affecting the ability to give voluntary informed consent.
- •Be able to read and understand English
排除标准
- •Participants currently on menses
- •Inability to provide Informed Consent
- •Previous total hysterectomy
- •History of radiation treatment for cervical cancer
- •Pregnancy
- •Medical condition that interferes with conduct of study, in investigator's opinion
- •Evidence of active cervical infection requiring treatment
- •Known bleeding diathesis
结局指标
主要结局
Comparison of the samples for the Predicate Device versus PPS device
时间窗: Baseline
Data of Adequate versus Inadequate will be reported to include a positive percent agreement (PPA) defined as PPA= A/(A+C) and the negative percent agreement (NPA) defined as NPA = D/(B+D) along with their 95% confidence bounds using the Clopper-Pearson method.
次要结局
- The Comparison of Cell Types of the PPS Device versus the Predicate Device(Baseline)
- The Comparison of Cell Types of the PPS Device versus the Predicate Device(Baseline)
研究者
Regina Leonis
Assistant Professor
Morehouse School of Medicine