Back to resultsDevelopment of a Self-collection Device for Cervical Cancer Screening
Primary Purpose
Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Human Papilloma Virus
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Teal Health Self-Collection Device Group
Sponsored by
About this trial
This is an interventional screening trial for Human Papilloma Virus Infection Type 16 focused on measuring cervical cancer screening, high risk HPV, hrHPV
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Crescendo MD
- University of Colorado Anschutz Medical CampusRecruiting
- Woman's HospitalRecruiting
- Boston Metro
- Planned Parenthood Gulf CoastRecruiting
- University of Wisconsin - MadisonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Teal Health Self-Collection Device Group
Arm 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.
Outcomes
Primary Outcome Measures
Primary Safety: SAEs
Evaluate SAEs to confirm that SAEs from self-collection are equivalent to the rate of SAEs from health care provider-collection
Primary Effectiveness: Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
Detection of high risk HPV in self-collected as compared to clinician-collected sample results.
Primary Effectiveness: Sample Inadequacy Rate
Sample inadequacy rate defined as percent of high risk HPV DNA concentrations below the detection thresholds as determined by the manufacturer.
Secondary Outcome Measures
Usability Survey
Usability Survey data will be analyzed to determine device design issues (There is no scale - questions are assessed individually)
Satisfaction and Needs Survey
Satisfaction and Needs Survey data will be used to assess subjects' general willingness to use an HPV self-collection device, and concerns about HPV self-collection. (There is no scale - questions are assessed individually)
Rate of sample adequacy for liquid-based cytology analysis
Samples will be assessed to determine if there is an adequate number of cells for liquid-based cytology analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05669911
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teal Health, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Human Papilloma Virus
Keywords
cervical cancer screening, high risk HPV, hrHPV
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Teal Health Self-Collection Device Group
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Teal Health Self-Collection Device Group
Intervention 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.
Primary Outcome Measure Information:
Title
Primary Safety: SAEs
Description
Evaluate SAEs to confirm that SAEs from self-collection are equivalent to the rate of SAEs from health care provider-collection
Time Frame
Acute - immediately after self-collection procedure
Title
Primary Effectiveness: Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
Description
Detection of high risk HPV in self-collected as compared to clinician-collected sample results.
Time Frame
Up to 30 days
Title
Primary Effectiveness: Sample Inadequacy Rate
Description
Sample inadequacy rate defined as percent of high risk HPV DNA concentrations below the detection thresholds as determined by the manufacturer.
Time Frame
Up to 30 days
Secondary Outcome Measure Information:
Title
Usability Survey
Description
Usability Survey data will be analyzed to determine device design issues (There is no scale - questions are assessed individually)
Time Frame
Immediately After Self-collection Procedure
Title
Satisfaction and Needs Survey
Description
Satisfaction and Needs Survey data will be used to assess subjects' general willingness to use an HPV self-collection device, and concerns about HPV self-collection. (There is no scale - questions are assessed individually)
Time Frame
Immediately After Self-collection Procedure
Title
Rate of sample adequacy for liquid-based cytology analysis
Description
Samples will be assessed to determine if there is an adequate number of cells for liquid-based cytology analysis
Time Frame
Up to 30 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trena Depel
Phone
925-918-0595
Email
trena@tealhealth.co
Facility Information:
Facility Name
Crescendo MD
City
Portola Valley
State/Province
California
ZIP/Postal Code
94028
Country
United States
Individual Site Status
Completed
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jocelyn Phipers
Phone
303-724-7807
Email
jocelyn.phipers@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Christine Conageski, MD
Facility Name
Woman's Hospital
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ateshi Bhatt
Phone
225-877-9047
Email
ateshi.bhatt@womans.org
First Name & Middle Initial & Last Name & Degree
Elizabeth Sutton, PhD
Facility Name
Boston Metro
City
Westwood
State/Province
Massachusetts
ZIP/Postal Code
02090
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Planned Parenthood Gulf Coast
City
Houston
State/Province
Texas
ZIP/Postal Code
77023
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Hernandez
Phone
713-831-6540
Email
linda.hernandez@ppgulfcoast.org
First Name & Middle Initial & Last Name & Degree
LaShonda Crane, DNP, FNP-C
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Wasielewski
Phone
608-417-4230
Email
obgyn.research@obgyn.wisc.edu
First Name & Middle Initial & Last Name & Degree
Ashley Jennings, MD
12. IPD Sharing Statement
Learn more about this trial
Development of a Self-collection Device for Cervical Cancer Screening
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