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
- 1
- 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
研究组 & 干预措施
Pap smear collection using the Personal Pap Smear (PPS) Device
The investigational device, trade named the Personal Pap Smear™ (PPS) developed by GyneConcepts of Atlanta, Georgia. It arrives completely assembled, and ready-for-use, in a sealed plastic bag. The PPS device is a multi-component assembly designed for the collection of exfoliated cervical epithelial cells. Its four major components are the (1) Tube Body, (2) U-Ring and attached Aligning Spoon, (3) Ball Handle, (with permanently anchored bristle Collection Brush), and (4) Safety Cover.
干预措施: Pap smear collection using the Personal Pap Smear (PPS) Device (Device)
Pap smear collection using the Rovers Cervex-Brush
The Predicate device utilized in this study is the Cervix-Examination Brush, manufactured by Rover (Manufacturers Code: 9443). The Cervex-Brush (CervixExamination Brush) is made of polyethylene and has a total length of 20 centimeters. The top portion uses a soft flexible brush to obtain cell samples. The brush consists of 57 semi-circular plastic bristles of various lengths. The shape is such that the top edges of the brush follow the contours of the cervix. The longer middle bristles reach deep into the endocervical canal- 'Os'. The shorter bristles touch both the ectocervical area and transformation zone at the same time. This device is packaged with identical standards used for packaging commercial tampons.
干预措施: Active Comparator: Pap smear collection using the Rovers Cervex-Brush (Device)
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