Teal Wand Self-Collection Device Group: Participants will use the Instructions for Use to perform self-collection of vaginal cells and material using the Teal Wand Self-Collection Device, and will fill out a usability survey and a satisfaction and needs survey. A healthcare provider collected sample will be performed by a clinician after self-collection. The patient will serve as their own comparator/control.
Study summary
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.
Eligibility
Sex
FEMALE
Min age
25 Years
Max age
65 Years
Healthy volunteers
Accepted
Group 1: Inclusion Criteria - General Population Group
1. Participant is 25 to 65 years of age and willing to provide informed consent.
2. Participant has an intact cervix.
Group 2: Inclusion Criteria - Enriched Population Group
1. Participant is 25 to 65 years of age and willing to provide informed consent.
2. Participant has an intact cervix.
3. 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
Exclusion Criteria - All Groups
1. Participant has impaired decision-making capacity or is unable to provide informed consent.
2. Participant has undergone partial or complete hysterectomy including removal of the cervix.
3. 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.
4. Participant is pregnant (based on self-reporting).
5. Participant who reports or is experiencing menstrual bleeding.
6. 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.
7. Any medical reason that, in the investigator's judgment, would disqualify the participant for a routine pelvic exam with cervical sample collection.
Primary outcome measure(s)
Efficacy: Detection of hrHPV in self-collect and clinician collect samples — 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
Safety: SAE rate — 6-14 days following collections SAE rate is equivalent for both self-collect and clinician collect interventions
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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