SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening
Running, not enrolling · Not applicable
Conditions studied: Hpv, HPV 16 Infection, HPV Infection, High Risk HPV
In brief
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.
Key facts
- Study ID
- NCT06120205
- Run by
- Teal Health, Inc.
- People needed
- 870
- Starts
- 2023-11-20
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-07-18
Who can join
Age: 25 and older, up to 65. Sex: female. Healthy volunteers: accepted.
Where it is running
- Birmingham OBGYN / Alabama Clinical Therapeutics — Birmingham, Alabama, United States
- Planned Parenthood Northern California — San Francisco, California, United States
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
- Planned Parenthood Southern New England — New Haven, Connecticut, United States
- Yale University — New Haven, Connecticut, United States
- Woman's Hospital — Baton Rouge, Louisiana, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- Planned Parenthood League of Massachusetts — Boston, Massachusetts, United States
- Planned Parenthood St. Louis Region — St Louis, Missouri, United States
- Washington University — St Louis, Missouri, United States
- New York University Langone Hospital — Mineola, New York, United States
- Unified Women's Clinical Research Raleigh — Raleigh, North Carolina, United States
- Unified Women's Clinical Research - Lyndhurst — Winston-Salem, North Carolina, United States
- Planned Parenthood Gulf Coast — Houston, Texas, United States
- University of Wisconsin - Madison — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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