A Pilot Study for a Non-Inferiority Trial of Clinician-Collected Versus Patient-Collected Cervical Papanicolaou Smears
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests
研究概览
简要总结
The purpose of this study is to see if it is possible to conduct a full study to determine whether the SoloPap™ cervical cell sample collection kit is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females.
Begin to determine patient attitudes regarding ease of use and discomfort using SoloPap.
详细描述
The SoloPap "kit" provides to subjects who would not otherwise have a Pap smear done a convenient and private way to collect samples and ship them to a laboratory for processing. The current study is pilot/pre-cursor study for a larger subsequent study that aims to determine whether SoloPap is truly noninferior to clinician-collected Pap smears in detecting cervical pathology. It will also determine user preference and willingness to perform a self- test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
- •All women at least 18 yrs of presenting for Pap Smear who have not previously participated in this protocol. SoloPap can be performed any day that a woman is not having vaginal bleeding
排除标准
- •Age <18 years (not recommended for Pap Smear)
- •Known pregnancy
- •Women who have had a total hysterectomy (cervix removed)
- •Women with vaginal bleeding
- •Persons who report a history of severe neuropathy or arthritis of the hands or those having other major problems with dexterity of the hands
结局指标
主要结局
Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests
时间窗: 1 hour
whether the SoloPap™ cervical cell sample collection kit used by the subject (patient) is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females.
次要结局
- Patient Opinions(Directly after interventions (Solo Pap and physician-collected pap smear samples))