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临床试验/NCT05034614
NCT05034614已完成不适用

Pap Smear Collection With the Papette Brush: A Pragmatic Study

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 756 人开始时间: 2021年8月18日最近更新:
适应症

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
2
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

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.

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Danielle J. O'Laughlin

Principal Investigator

Mayo Clinic

研究点 (2)

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