Pap Smear Collection With the Papette Brush: A Pragmatic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 756
- 试验地点
- 1
- 主要终点
- Specimen Adequacy
研究概览
简要总结
This research study is comparing Pap smear collection techniques using the Papette brush to traditional spatula and cytology brush for cervical cancer screening
详细描述
At the investigators institution the investigators have been using both the traditional spatula and cytology and the Papette brush for Pap smear collection. The investigators will be comparing adequacy of sample rates, provider perceived pain and bleeding and overall satisfaction with each collection technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult women, aged 21-64 years old.
- •Have given consent for medical records to be accessed.
- •Who will have a Pap smear exam in CIM from July 2021 through June 2022.
排除标准
- •Women, age < 21 or >
- •Has vaginal spotting present during cervical sampling.
- •Did not give consent to have medical records accessed.
研究组 & 干预措施
Pap smears using the Papette
Papette brush used to collect a Pap smear sample as standard of care.
干预措施: Papette brush collection (Diagnostic Test)
Pap smears using the traditional spatula/cytology brush
Spatula/cytology brush used to collect a Pap smear sample as standard of care.
干预措施: Spatula/cytology brush collection (Diagnostic Test)
结局指标
主要结局
Specimen Adequacy
时间窗: Baseline
Number of subjects who's samples have cervical cellular adequacy for a satisfactory evaluation indicated on the cytology report
次要结局
- Perceived Pain(Baseline)
- Cervical Bleeding With Collection(Baseline)
- Collection Time(Baseline)
研究者
Danielle J. O'Laughlin
Principal Investigator
Mayo Clinic