Clinical trial · Interventional
Development of a Self-collection Device for Cervical Cancer Screening
Pilot Study: Evaluation of a Novel Self-Collection Device for Cervical Cancer Screening
NCT05669911CI-TRIAL-00071007active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Evaluation of a novel self-collection device for cervical cancer screening.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papilloma Virus | — | UNRESOLVED | — |
| Human Papilloma Virus Infection Type 16 | — | UNRESOLVED | — |
| Human Papilloma Virus Infection Type 18 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Teal Health Self-Collection Device Group | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Teal Health Self-Collection Device Group
- description
- 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.
- interventionNames
- Device: Teal Health Self-Collection Device Group
Primary outcomes (3)
- measure
- Primary Safety: SAEs
- timeFrame
- Acute - immediately after self-collection procedure
- description
- Evaluate SAEs to confirm that SAEs from self-collection are equivalent to the rate of SAEs from health care provider-collection
- measure
- Primary Effectiveness: Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: Group 1: Inclusion Criteria - General Population Group 1. Subject is 25 to 65 years of age and willing to provide informed consent. 2. Subject with intact cervix. Group 2: Inclusion Criteria - HPV positive Population Group (HPV+ Enriched Group) 1. Subject is 25 to 65 years of age and willing to provide informed consent. 2. Subject with intact cervix. 3. Prior diagnosis of high risk HPV and/or positive cytology and/or presenting for colposcopy. Exclusion Criteria: 1. Subject who reports current menstruation. 2. Subject is pregnant (based on self-reporting). 3. Subject has impaired decision-making capacity or unable to provide informed consent. 4. 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. 5. Subject has undergone partial or complete hysterectomy including removal of the cervix. 6. 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. 7. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.