HpvNCT06120205
SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening
A study testing Teal Wand Self-Collection Device Group in people with Hpv and HPV 16 Infection, run by Teal Health, Inc. at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hpv, HPV 16 Infection, HPV Infection
- What is being tested?
- Teal Wand Self-Collection Device Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 870 participants
- Where
- 15 sitesUnited States
- Study dates
- 20 Nov 2023to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21287
Woman's Hospital
Baton Rouge, Louisiana, 70817
Birmingham OBGYN / Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
Planned Parenthood League of Massachusetts
Boston, Massachusetts, 02215
Planned Parenthood Gulf Coast
Houston, Texas, 77023
University of Wisconsin - Madison
Madison, Wisconsin, 53715
New York University Langone Hospital
Mineola, New York, 11501
Planned Parenthood Southern New England
New Haven, Connecticut, 06511
Yale University
New Haven, Connecticut, 06520
Unified Women's Clinical Research Raleigh
Raleigh, North Carolina, 27607
Planned Parenthood Northern California
San Francisco, California, 94109
Planned Parenthood St. Louis Region
St Louis, Missouri, 62208
Washington University
St Louis, Missouri, 63110
Unified Women's Clinical Research - Lyndhurst
Winston-Salem, North Carolina, 27103
About this study
Official title: 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
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.
Read the detailed 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.
- Conditions
- Hpv, HPV 16 Infection, HPV Infection, High Risk HPV
- Being tested
- Teal Wand Self-Collection Device Group
- Keywords
- screening, self-collect, HPV, cervical cancer screening
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teal Wand Self-Collection Device GroupDevice
Also called Clinician Collection
Participants will use the Instructions for Use to perform self-collection of vaginal cells and material using the Teal Wand Self-Collection Device, and will fill out a usability survey and a satisfaction and needs survey. A healthcare provider collected sample will be performed by a clinician after self-collection. The patient will serve as their own comparator/control.
| Study group | Role | What they receive |
|---|---|---|
| Self-Collection / Clinician Collection | Other | Patient serves as own comparator/control in this method comparison study where the investigational intervention is use of the self-collect device and the comparator is the standard of care clinician collection. Receives: Device: Teal Wand Self-Collection Device Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Detection of hrHPV in self-collect and clinician collect samples
PPA/NPA (Positive Percent Agreement)/(Negative Percent Agreement) of hrHPV detection of self-collected and clinician collected samples
Measured: Samples tested within 7 days of collection
Safety: SAE rate
SAE rate is equivalent for both self-collect and clinician collect interventions
Measured: 6-14 days following collections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start20 Nov 2023
- Primary completion5 Apr 2024
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HpvStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 870 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teal Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120205
- Sponsor's protocol ID
- CLN-TP-020
- Status last verified
- Jul 2025
- First submitted
- 27 Oct 2023
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: De-identified results only
Publications
Fitzpatrick MB, Behrens CM, Hibler K, Parsons C, Kaplan C, Orso R, Parker L, Memmel L, Collins A, McNicholas C, Crane L, Hwang Y, Sutton E, Coleman J, Kuroki L, Harshberger K, Williams S, Jennings A, Buccini F, Gillis L, Novetsky AP, Hawkes D, Saville M, Depel T, Aviki E, Sheth SS, Conageski C. Clinical Validation of a Vaginal Cervical Cancer Screening Self-Collection Method for At-Home Use: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2511081. doi: 10.1001/jamanetworkopen.2025.11081.
PubMed 40388167
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06120205
- Acronym / sponsor ID
- CLN-TP-020
- Conditions
- Hpv, HPV 16 Infection, HPV Infection, High Risk HPV
- Keywords
- screening, self-collect, HPV, cervical cancer screening
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 870 participants (estimated)
- Lead sponsor
- Teal Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-Collection / Clinician Collection | Other | Device: Teal Wand Self-Collection Device GroupPatient serves as own comparator/control in this method comparison study where the investigational intervention is use of the self-collect device and the comparator is the standard of care clinician collection. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teal Wand Self-Collection Device GroupAlso: Clinician CollectionParticipants will use the Instructions for Use to perform self-collection of vaginal cells and material using the Teal Wand Self-Collection Device, and will fill out a usability survey and a satisfaction and needs survey. A healthcare provider collected sample will be performed by a clinician after self-collection. The patient will serve as their own comparator/control. | Device | Self-Collection / Clinician Collection |
Primary outcome
Efficacy: Detection of hrHPV in self-collect and clinician collect samples
Time frame: Samples tested within 7 days of collection
PPA/NPA (Positive Percent Agreement)/(Negative Percent Agreement) of hrHPV detection of self-collected and clinician collected samples
Safety: SAE rate
Time frame: 6-14 days following collections
SAE rate is equivalent for both self-collect and clinician collect interventions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Background: PubMed 40388167Fitzpatrick MB, Behrens CM, Hibler K, Parsons C, Kaplan C, Orso R, Parker L, Memmel L, Collins A, McNicholas C, Crane L, Hwang Y, Sutton E, Coleman J, Kuroki L, Harshberger K, Williams S, Jennings A, Buccini F, Gillis L, Novetsky AP, Hawkes D, Saville M, Depel T, Aviki E, Sheth SS, Conageski C. Clinical Validation of a Vaginal Cervical Cancer Screening Self-Collection Method for At-Home Use: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2511081. doi: 10.1001/jamanetworkopen.2025.11081.
- Individual participant dataSharing planned: No. De-identified results only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teal Wand Self-Collection Device Group in people with Hpv and HPV 16 Infection, run by Teal Health, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Detection of hrHPV in self-collect and clinician collect samples (time frame: Samples tested within 7 days of collection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06120205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.