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
- Study HIC#:2000035973
- Last Updated:01/19/2024
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.
- Age25 years - 65 years
- GenderFemale only
Contact Us
For more information about this study, including how to volunteer, contact:
Sangini S Sheth
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Trial Purpose and Description
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.
Eligibility Criteria
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
Exclusion Criteria - 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.