Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Risk HPV | — | UNRESOLVED | — |
| Hpv | — | UNRESOLVED | — |
| HPV 16 Infection | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Teal Wand Self-Collection Device Group | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Self-Collection / Clinician Collection
- description
- 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.
- interventionNames
- Device: Teal Wand Self-Collection Device Group
Primary outcomes (2)
- measure
- Efficacy: Detection of hrHPV in self-collect and clinician collect samples
- timeFrame
- Samples tested within 7 days of collection
- description
- PPA/NPA (Positive Percent Agreement)/(Negative Percent Agreement) of hrHPV detection of self-collected and clinician collected samples
- measure
- Safety: SAE rate
- timeFrame
- 6-14 days following collections
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Group 1: Inclusion Criteria - General Population Group 1. Participant is 25 to 65 years of age and willing to provide informed consent. 2. Participant has an intact cervix. Group 2: Inclusion Criteria - Enriched Population Group 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 - All Groups 1. Participant has impaired decision-making capacity or is unable to provide informed consent. 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.
References
Publications (1)
- BACKGROUNDFitzpatrick 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. PMID 40388167