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NCT06120205 · ClinicalTrials.gov registry record · NA
SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening
A NA study of Hpv and HPV Infection, sponsored by Teal Health.
- Active
- Registry status
- NA
- Development phase
- 870
- Enrollment target
- 15
- Study locations
NCT06120205: Active NA study of Hpv and HPV Infection, sponsored by Teal Health.
NCT06120205 is a NA study of Hpv and HPV Infection that is active but no longer recruiting, run by Teal Health. The registered enrollment target is 870 participants, below the 2,205-participant average among 24 other Hpv trials with a reported enrollment target (61% lower). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06120205, a NA study of Hpv and HPV Infection, is active but no longer recruiting, sponsored by Teal Health.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 870 participants
- Enrollment target
- 15
- Study locations
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.
Primary Outcome
PPA/NPA (Positive Percent Agreement)/(Negative Percent Agreement) of hrHPV detection of self-collected and clinician collected samples
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 |
What the registry record for NCT06120205 still lists
NCT06120205 is an interventional study that assigns participants to a tested intervention. The registered 870 participants enrollment target is mid-sized for trials with a published cap, below the 2,205-participant average among 24 other Hpv trials with a reported enrollment target (61% lower).
The record links to 4 conditions, with Hpv appearing as the primary indexed condition, and to 1 intervention - of which Teal Wand Self-Collection Device Group is the first listed.
NCT06120205 lists 15 locations in 12 states (Connecticut, Missouri, North Carolina).
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, HPV Infection, HPV 16 Infection, High Risk HPV.
What interventions are being tested in trial NCT06120205?
The interventions under investigation include: Teal Wand Self-Collection Device Group (DEVICE).
Who is sponsoring clinical trial NCT06120205?
This trial is sponsored by Teal Health, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06120205's enrollment target sits among peer trials
870 7th of 24 higher than 18 of 24 other Hpv trials
participants (enrollment target), bucketed by value
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