Pilot Study: Evaluation of a Novel Self-Collection Device for Cervical Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 235
- 试验地点
- 12
- 主要终点
- Primary Safety: SAEs
研究概览
简要总结
Evaluation of a novel self-collection device for cervical cancer screening.
详细描述
The purpose of this study is to collect design and user input on the safety and effectiveness of the Teal Health self-collection device for patient self-collection of cervicovaginal samples for use with FDA-approved in vitro diagnostics indicated for high risk Human Papillomavirus (hrHPV) screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Group 1: Inclusion Criteria - General Population Group
- •Subject is 25 to 65 years of age and willing to provide informed consent.
- •Subject with intact cervix.
- •Group 2: Inclusion Criteria - HPV positive Population Group (HPV+ Enriched Group)
- •Subject is 25 to 65 years of age and willing to provide informed consent.
- •Subject with intact cervix.
- •Prior diagnosis of high risk HPV and/or positive cytology and/or presenting for colposcopy.
排除标准
- •Subject who reports current menstruation.
- •Subject is pregnant (based on self-reporting).
- •Subject has impaired decision-making capacity or unable to provide informed consent.
- •Subject is participating in another clinical study for an investigational device, drug, or biologic that, in the investigator's opinion, would interfere with the results of this study.
- •Subject has undergone partial or complete hysterectomy including removal of the cervix.
- •Subject has applied any chemical compounds to the cervical area within the 24-hours prior to study sample collection, including iodine, spermicide, douche, anti-fungal medications, generally, and specifically: Replens vaginal moisturizer and RepHresh vaginal hygiene products.
- •Subject on whom any form of cervical tissue alteration or surgery has been performed within the prior year, including: conization, Loop electrosurgical excision procedure (LEEP), laser surgery, or cryosurgery.
结局指标
主要结局
Primary Safety: SAEs
时间窗: Acute - immediately after self-collection procedure
Evaluate SAEs to confirm that SAEs from self-collection are equivalent to the rate of SAEs from health care provider-collection
Primary Effectiveness: Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
时间窗: Up to 30 days
Detection of high risk HPV in self-collected as compared to clinician-collected sample results.
Primary Effectiveness: Sample Inadequacy Rate
时间窗: Up to 30 days
Sample inadequacy rate defined as percent of high risk HPV DNA concentrations below the detection thresholds as determined by the manufacturer.
次要结局
- Usability Survey(Immediately After Self-collection Procedure)
- Satisfaction and Needs Survey(Immediately After Self-collection Procedure)
- Rate of sample adequacy for liquid-based cytology analysis(Up to 30 days)