Active — Not RecruitingNot Applicable

Development of a Self-collection Device for Cervical Cancer Screening

United States235 participantsStarted 2022-08-28

Plain-language summary

Evaluation of a novel self-collection device for cervical cancer screening.

Age range25 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subject is 25 to 65 years of age and willing to provide informed consent.
✓. Subject with intact cervix.
✓. 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.

✕. 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.

Primary Safety: SAEs

Timeframe: Acute - immediately after self-collection procedure

Primary Effectiveness: Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)

Timeframe: Up to 30 days

Primary Effectiveness: Sample Inadequacy Rate

Timeframe: Up to 30 days

NCT IDNCT05669911

SponsorTeal Health, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-06

Who can participate

Age range25 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subject is 25 to 65 years of age and willing to provide informed consent.
✓. Subject with intact cervix.
✓. 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.

✕. 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.