Clinical trial NCT05669911: Development of a Self-collection Device for Cervical Cancer Screening
Official title: Pilot Study: Evaluation of a Novel Self-Collection Device for Cervical Cancer Screening
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Human Papilloma Virus Infection Type 16
Human Papilloma Virus Infection Type 18
Human Papilloma Virus
Keywords: cervical cancer screening
high risk HPV
hrHPV
Lead sponsor: Teal Health, Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-03
Enrollment: 235
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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

Detailed description: The purpose of this study is to collect design and user input on the safety and effectiveness of the Teal Health self-collection device for patient self-collection of cervicovaginal samples for use with FDA-approved in vitro diagnostics indicated for high risk Human Papillomavirus (hrHPV) screening.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Safety: SAEs
timeFrame: Acute - immediately after self-collection procedure
measure: Primary Effectiveness: Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
timeFrame: Up to 30 days
measure: Primary Effectiveness: Sample Inadequacy Rate
timeFrame: Up to 30 days
Secondary outcomes:
measure: Usability Survey
timeFrame: Immediately After Self-collection Procedure
measure: Satisfaction and Needs Survey
timeFrame: Immediately After Self-collection Procedure
measure: Rate of sample adequacy for liquid-based cytology analysis
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Portola Valley
country: United States
facility: Crescendo MD
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Baton Rouge
country: United States
facility: Woman's Hospital
state: Louisiana
city: Westwood
country: United States
facility: Boston Metro
state: Massachusetts
city: Houston
country: United States
facility: Planned Parenthood Gulf Coast
state: Texas
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
References: