NCT06120205Active, not recruiting
SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening
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
Source: ClinicalTrials.gov · Last updated 18 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 870 (estimated)
- First submitted
- 27 Oct 2023
- Start date
- 20 Nov 2023
- Primary completion date
- 5 Apr 2024
- Lead sponsor
- Teal Health, Inc.
- Diseases
- Cervical cancer
- NCT number
- NCT06120205
What you commit to
- Study type: Interventional
- Planned participants: 870
- From 20 Nov 2023 to the primary completion date, 5 Apr 2024
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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.
Other illness
- Participant who reports or is experiencing menstrual bleeding.
Other
- 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 is pregnant (based on self-reporting).
- Any medical reason that, in the investigator's judgment, would disqualify the participant for a routine pelvic exam with cervical sample collection.
Criteria the registry did not label
- 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
Age in the registry: 25 years to 65 years · Sex: Female · Accepts healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Woman's Hospital Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| Birmingham OBGYN / Alabama Clinical Therapeutics Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Planned Parenthood League of Massachusetts Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Planned Parenthood Gulf Coast Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Wisconsin - Madison Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| New York University Langone Hospital Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Planned Parenthood Southern New England Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Unified Women's Clinical Research Raleigh Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| Planned Parenthood Northern California Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Planned Parenthood St. Louis Region Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Unified Women's Clinical Research - Lyndhurst Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.