Human Papilloma Virus Infection Type 16NCT05669911
Development of a Self-collection Device for Cervical Cancer Screening
A study testing Teal Health Self-Collection Device Group in people with Human Papilloma Virus Infection Type 16 and Human Papilloma Virus Infection Type 18, run by Teal Health, Inc. at 6 sites in United States.
Trial summary
Evaluation of a novel self-collection device for cervical cancer screening. 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
- Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Human Papilloma Virus
- What is being tested?
- Teal Health Self-Collection Device Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 6 sitesUnited States
- Study dates
- 28 Aug 2022to 31 Dec 2023
- 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
- Group 1: Inclusion Criteria - General Population Group
- Subject is 25 to 65 years of age and willing to provide informed consent.
- Subject with intact cervix.
- Group 2: Inclusion Criteria - HPV positive Population Group (HPV+ Enriched Group)
- Subject is 25 to 65 years of age and willing to provide informed consent.
- Subject with intact cervix.
- Prior diagnosis of high risk HPV and/or positive cytology and/or presenting for colposcopy.
Who cannot join
- Subject who reports current menstruation.
- Subject is pregnant (based on self-reporting).
- Subject has impaired decision-making capacity or unable to provide informed consent.
- Subject 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.
- Subject has undergone partial or complete hysterectomy including removal of the cervix.
- Subject has applied any chemical compounds to the cervical area within the 24-hours prior to study sample collection, including iodine, spermicide, douche, anti-fungal medications, generally, and specifically: Replens vaginal moisturizer and RepHresh vaginal hygiene products.
- Subject on whom any form of cervical tissue alteration or surgery has been performed within the prior year, including: conization, Loop electrosurgical excision procedure (LEEP), laser surgery, or cryosurgery.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Woman's Hospital
Baton Rouge, Louisiana, 70817
Planned Parenthood Gulf Coast
Houston, Texas, 77023
University of Wisconsin - Madison
Madison, Wisconsin, 53715
Crescendo MD
Portola Valley, California, 94028
Boston Metro
Westwood, Massachusetts, 02090
About this study
Official title: Pilot Study: Evaluation of a Novel Self-Collection Device for Cervical Cancer Screening
Evaluation of a novel self-collection device for cervical cancer screening.
Read the detailed description
The purpose of this study is to collect design and user input on the safety and effectiveness of the Teal Health self-collection device for patient self-collection of cervicovaginal samples for use with FDA-approved in vitro diagnostics indicated for high risk Human Papillomavirus (hrHPV) screening.
- Conditions
- Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Human Papilloma Virus
- Being tested
- Teal Health Self-Collection Device Group
- Keywords
- cervical cancer screening, high risk HPV, hrHPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teal Health Self-Collection Device GroupDevice
Participants will use the Instructions for Use to perform self-collection of cervicovaginal cells using the Teal Health Self-Collection Device, and will fill out a usability survey and a satisfaction and needs survey. A Pap smear will be performed by a clinician before or after self-collection.
| Study group | Role | What they receive |
|---|---|---|
| Teal Health Self-Collection Device Group | Experimental | This group will use the Teal Health Self-Collection Device to evaluate the instructions for use, usability, and satisfaction with the self-collection device. Participants will also undergo a Pap smear performed by a clinician. Self-collected and clinician-collected research samples will undergo HPV testing and cytological analysis using tests that are FDA-approved for use for HPV and Pap cytology. Receives: Device: Teal Health Self-Collection Device Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety: SAEs
Evaluate SAEs to confirm that SAEs from self-collection are equivalent to the rate of SAEs from health care provider-collection
Measured: Acute - immediately after self-collection procedure
Primary Effectiveness: Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
Detection of high risk HPV in self-collected as compared to clinician-collected sample results.
Measured: Up to 30 days
Primary Effectiveness: Sample Inadequacy Rate
Sample inadequacy rate defined as percent of high risk HPV DNA concentrations below the detection thresholds as determined by the manufacturer.
Measured: Up to 30 days
Secondary outcomes (3)
Usability Survey
Usability Survey data will be analyzed to determine device design issues (There is no scale - questions are assessed individually)
Measured: Immediately After Self-collection Procedure
Satisfaction and Needs Survey
Satisfaction and Needs Survey data will be used to assess subjects' general willingness to use an HPV self-collection device, and concerns about HPV self-collection. (There is no scale - questions are assessed individually)
Measured: Immediately After Self-collection Procedure
Rate of sample adequacy for liquid-based cytology analysis
Samples will be assessed to determine if there is an adequate number of cells for liquid-based cytology analysis
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study start28 Aug 2022
- Primary completion6 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma Virus Infection Type 16Studies 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
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teal Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669911
- Sponsor's protocol ID
- TLH-ED-004
- Status last verified
- Oct 2023
- First submitted
- 8 Nov 2022
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Evaluation of a Novel Self-Collection Device for Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT05669911
- Acronym / sponsor ID
- TLH-ED-004
- Conditions
- Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Human Papilloma Virus
- Keywords
- cervical cancer screening, high risk HPV, hrHPV
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Teal Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2022 (actual)
- Primary completion
- 6 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Jan 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.
Evaluation of a novel self-collection device for cervical cancer screening.
Detailed description
The purpose of this study is to collect design and user input on the safety and effectiveness of the Teal Health self-collection device for patient self-collection of cervicovaginal samples for use with FDA-approved in vitro diagnostics indicated for high risk Human Papillomavirus (hrHPV) screening.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teal Health Self-Collection Device Group | Experimental | Device: Teal Health Self-Collection Device GroupThis group will use the Teal Health Self-Collection Device to evaluate the instructions for use, usability, and satisfaction with the self-collection device. Participants will also undergo a Pap smear performed by a clinician. Self-collected and clinician-collected research samples will undergo HPV testing and cytological analysis using tests that are FDA-approved for use for HPV and Pap cytology. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Group 1: Inclusion Criteria - General Population Group
- Subject is 25 to 65 years of age and willing to provide informed consent.
- Subject with intact cervix.
- Group 2: Inclusion Criteria - HPV positive Population Group (HPV+ Enriched Group)
- Subject is 25 to 65 years of age and willing to provide informed consent.
Key exclusion criteria (7 listed)
- Subject who reports current menstruation.
- Subject is pregnant (based on self-reporting).
- Subject has impaired decision-making capacity or unable to provide informed consent.
- Subject 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.
- Subject has undergone partial or complete hysterectomy including removal of the cervix.
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 Health Self-Collection Device GroupParticipants will use the Instructions for Use to perform self-collection of cervicovaginal cells using the Teal Health Self-Collection Device, and will fill out a usability survey and a satisfaction and needs survey. A Pap smear will be performed by a clinician before or after self-collection. | Device | Teal Health Self-Collection Device Group |
Primary outcome
Primary Safety: SAEs
Time frame: Acute - immediately after self-collection procedure
Evaluate SAEs to confirm that SAEs from self-collection are equivalent to the rate of SAEs from health care provider-collection
Primary Effectiveness: Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
Time frame: Up to 30 days
Detection of high risk HPV in self-collected as compared to clinician-collected sample results.
Primary Effectiveness: Sample Inadequacy Rate
Time frame: Up to 30 days
Sample inadequacy rate defined as percent of high risk HPV DNA concentrations below the detection thresholds as determined by the manufacturer.
3 secondary outcomes
Usability Survey
Time frame: Immediately After Self-collection Procedure
Satisfaction and Needs Survey
Time frame: Immediately After Self-collection Procedure
Rate of sample adequacy for liquid-based cytology analysis
Time frame: Up to 30 days
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 2 Nov 2023.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teal Health Self-Collection Device Group in people with Human Papilloma Virus Infection Type 16 and Human Papilloma Virus Infection Type 18, run by Teal Health, Inc. at 6 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 7 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 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Primary Safety: SAEs (time frame: Acute - immediately after self-collection procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2023; AzTrials last refreshed its copy on 26 Oct 2026.