Development of a Self-collection Device for Cervical Cancer Screening
Running, not enrolling · Not applicable
Conditions studied: Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Human Papilloma Virus
In brief
Evaluation of a novel self-collection device for cervical cancer screening.
Key facts
- Study ID
- NCT05669911
- Run by
- Teal Health, Inc.
- People needed
- 235
- Starts
- 2022-08-28
- Expected to finish
- 2023-12-31
- Last updated by the study team
- 2023-11-02
Who can join
Age: 25 and older, up to 65. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Crescendo MD — Portola Valley, California, United States
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
- Woman's Hospital — Baton Rouge, Louisiana, United States
- Boston Metro — Westwood, Massachusetts, United States
- Planned Parenthood Gulf Coast — Houston, Texas, United States
- University of Wisconsin - Madison — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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