SELF-CERV Pivotal Study: Method Comparison of Self-collection Using the Teal Wand Self-Collection Device and HCP (Health Care Provider) Cervical Collection for Detection of High-risk HPV (hrHPV) 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
- 870
- 试验地点
- 15
- 主要终点
- Safety: SAE rate
研究概览
简要总结
The goal of this method comparison study is to compare the detection of hrHPV collected using the Teal Wand Self-Collection device to hrHPV detected from HCP (health care provider) cervical collection using primary HPV testing assays.
Participants will be asked to use the Teal Wand to provide a self-collected sample prior to a healthcare provider collected sample to be tested for hrHPV. Secondary measure will include usability and preferences.
详细描述
To demonstrate that participants who are representative of the intended use population can understand the Instructions for Use (IFU) and appropriately use the Teal self-collection device to collect adequate vaginal cells/material for use in primary hrHPV screening (primary outcome).
To produce sufficient primary hrHPV test results following self-collection, as compared to the current SoC method of HCP specimen collection, when paired samples are tested using FDA approved primary hrHPV assays (Roche cobas and/or BD OnClarity).
Primary Effectiveness Objective
• To evaluate the performance of a self-collect device for hrHPV detection as compared to standard of care (SoC) by:
- Agreement of hrHPV self-collected sample(s) as compared to HCP-collected sample results.
- Calculating the invalid rate of tested samples.
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
- •Participant is 25 to 65 years of age and willing to provide informed consent.
- •Participant has an intact cervix.
- •Group 2: Inclusion Criteria - Enriched Population Group
- •Participant is 25 to 65 years of age and willing to provide informed consent.
- •Participant has an intact cervix.
- •One or more of the below:
- •Prior diagnosis of hrHPV within previous 6 months and/or
- •Positive cervical Pap cytology result (ASCUS, ASC-H, LSIL, HSIL, SCC, AIS) within previous 6 months and/or
- •Presenting for colposcopy/LEEP/excisional intervention
排除标准
- •All Groups
- •Participant has impaired decision-making capacity or is unable to provide informed consent.
- •Participant has undergone partial or complete hysterectomy including removal of the cervix.
- •Participant on whom any form of cervical tissue alteration or surgery has been performed within the prior < 5 months, including: conization, loop electrosurgical excision procedure (LEEP), laser ablative surgery, or cryotherapy.
- •Participant is pregnant (based on self-reporting).
- •Participant who reports or is experiencing menstrual bleeding.
- •Participant 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.
- •Any medical reason that, in the investigator's judgment, would disqualify the participant for a routine pelvic exam with cervical sample collection.
研究组 & 干预措施
Self-Collection / Clinician Collection
Patient serves as own comparator/control in this method comparison study where the investigational intervention is use of the self-collect device and the comparator is the standard of care clinician collection.
干预措施: Teal Wand Self-Collection Device Group (Device)
结局指标
主要结局
Safety: SAE rate
时间窗: 6-14 days following collections
SAE rate is equivalent for both self-collect and clinician collect interventions
Efficacy: Detection of hrHPV in self-collect and clinician collect samples
时间窗: Samples tested within 7 days of collection
PPA/NPA (Positive Percent Agreement)/(Negative Percent Agreement) of hrHPV detection of self-collected and clinician collected samples
次要结局
未报告次要终点