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SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening
NCT06120205 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DEVICE Teal Wand Self-Collection Device Group
Study Locations (15)
Connecticut
- Planned Parenthood Southern New England — New Haven
- Yale University — New Haven
Missouri
- Planned Parenthood St. Louis Region — St Louis
- Washington University — St Louis
North Carolina
- Unified Women's Clinical Research Raleigh — Raleigh
- Unified Women's Clinical Research - Lyndhurst — Winston-Salem
Alabama
- Birmingham OBGYN / Alabama Clinical Therapeutics — Birmingham
California
- Planned Parenthood Northern California — San Francisco
Colorado
- University of Colorado Anschutz Medical Campus — Aurora
Louisiana
- Woman's Hospital — Baton Rouge
Maryland
- Johns Hopkins University — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 870 participants |
| Start Date | 2023-11-20 |
| Est. Completion | 2027-06-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06120205
The ClinicalTrials.gov registry entry for NCT06120205 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 870 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teal Health, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with HPV Infection appearing as the primary indexed condition, and to 1 intervention — of which Teal Wand Self-Collection Device Group is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06120205 reports 15 study locations spanning 12 distinct geographic areas — top geographies include Connecticut, Missouri, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06120205 about?
NCT06120205 is a clinical study titled "SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening". 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 sel...
What is the current status of trial NCT06120205?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 870 participants. The study started on 2023-11-20. Estimated completion is 2027-06-01.
What conditions does trial NCT06120205 study?
This clinical trial studies the following conditions: HPV Infection, Hpv, HPV 16 Infection, High Risk HPV. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06120205?
The interventions under investigation include: Teal Wand Self-Collection Device Group (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06120205?
This trial is sponsored by Teal Health, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06120205 being conducted?
This trial has 15 study locations across Alabama, California, Colorado, Connecticut, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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