SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening
NCT ID: NCT06120205
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
870 participants
INTERVENTIONAL
2023-11-20
2027-06-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Self-Collection / Clinician Collection
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.
Teal Wand Self-Collection Device Group
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.
Interventions
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Teal Wand Self-Collection Device Group
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant has an intact cervix.
1. Participant is 25 to 65 years of age and willing to provide informed consent.
2. Participant has an intact cervix.
3. 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
Exclusion Criteria
2. Participant has undergone partial or complete hysterectomy including removal of the cervix.
3. 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.
4. Participant is pregnant (based on self-reporting).
5. Participant who reports or is experiencing menstrual bleeding.
6. 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.
7. Any medical reason that, in the investigator's judgment, would disqualify the participant for a routine pelvic exam with cervical sample collection.
25 Years
65 Years
FEMALE
Yes
Sponsors
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Teal Health, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Onabolu AO, Oluwole OS, Bokanga M. Loss of residual cyanogens in a cassava food during short-term storage. Int J Food Sci Nutr. 2002 Jul;53(4):343-9. doi: 10.1080/09637480220138151.
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.
Other Identifiers
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CLN-TP-020
Identifier Type: -
Identifier Source: org_study_id
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