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Trial Title:
Development of a Self-collection Device for Cervical Cancer Screening
NCT ID:
NCT05669911
Condition:
Human Papilloma Virus Infection Type 16
Human Papilloma Virus Infection Type 18
Human Papilloma Virus
Conditions: Official terms:
Infections
Communicable Diseases
Virus Diseases
Papillomavirus Infections
Uterine Cervical Neoplasms
Papilloma
Conditions: Keywords:
cervical cancer screening
high risk HPV
hrHPV
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Teal Health Self-Collection Device Group
Description:
Participants will use the Instructions for Use to perform self-collection of
cervicovaginal cells using the Teal Health Self-Collection Device, and will fill out a
usability survey and a satisfaction and needs survey. A Pap smear will be performed by a
clinician before or after self-collection.
Arm group label:
Teal Health Self-Collection Device Group
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.
Criteria for 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.
Gender:
Female
Minimum age:
25 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Crescendo MD
Address:
City:
Portola Valley
Zip:
94028
Country:
United States
Facility:
Name:
University of Colorado Anschutz Medical Campus
Address:
City:
Aurora
Zip:
80045
Country:
United States
Facility:
Name:
Woman's Hospital
Address:
City:
Baton Rouge
Zip:
70817
Country:
United States
Facility:
Name:
Boston Metro
Address:
City:
Westwood
Zip:
02090
Country:
United States
Facility:
Name:
Planned Parenthood Gulf Coast
Address:
City:
Houston
Zip:
77023
Country:
United States
Facility:
Name:
University of Wisconsin - Madison
Address:
City:
Madison
Zip:
53715
Country:
United States
Start date:
August 28, 2022
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Teal Health, Inc.
Agency class:
Industry
Source:
Teal Health, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05669911
