Trial Title:
SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening
NCT ID:
NCT06120205
Condition:
Hpv
HPV 16 Infection
HPV Infection
High Risk HPV
Conditions: Official terms:
Infections
Communicable Diseases
Papillomavirus Infections
Uterine Cervical Neoplasms
Conditions: Keywords:
screening
self-collect
HPV
cervical cancer screening
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Teal Wand Self-Collection Device Group
Description:
Participants will use the Instructions for Use to perform self-collection of vaginal
cells and material using the Teal Wand Self-Collection Device, and will fill out a
usability survey and a satisfaction and needs survey. A healthcare provider collected
sample will be performed by a clinician after self-collection. The patient will serve as
their own comparator/control.
Arm group label:
Self-Collection / Clinician Collection
Other name:
Clinician Collection
Summary:
The goal of this method comparison study is to compare the detection of hrHPV collected
using the Teal Wand Self-Collection device to hrHPV detected from HCP (health care
provider) cervical collection using primary HPV testing assays.
Participants will be asked to use the Teal Wand to provide a self-collected sample prior
to a healthcare provider collected sample to be tested for hrHPV. Secondary measure will
include usability and preferences.
Detailed description:
To demonstrate that participants who are representative of the intended use population
can understand the Instructions for Use (IFU) and appropriately use the Teal
self-collection device to collect adequate vaginal cells/material for use in primary
hrHPV screening (primary outcome).
To produce sufficient primary hrHPV test results following self-collection, as compared
to the current SoC method of HCP specimen collection, when paired samples are tested
using FDA approved primary hrHPV assays (Roche cobas and/or BD OnClarity).
Primary Effectiveness Objective
• To evaluate the performance of a self-collect device for hrHPV detection as compared to
standard of care (SoC) by:
- Agreement of hrHPV self-collected sample(s) as compared to HCP-collected sample
results.
- Calculating the invalid rate of tested samples.
Criteria for eligibility:
Criteria:
Group 1: Inclusion Criteria - General Population Group
1. Participant is 25 to 65 years of age and willing to provide informed consent.
2. Participant has an intact cervix.
Group 2: Inclusion Criteria - Enriched Population Group
1. Participant is 25 to 65 years of age and willing to provide informed consent.
2. Participant has an intact cervix.
3. One or more of the below:
- Prior diagnosis of hrHPV within previous 6 months and/or
- Positive cervical Pap cytology result (ASCUS, ASC-H, LSIL, HSIL, SCC, AIS)
within previous 6 months and/or
- Presenting for colposcopy/LEEP/excisional intervention
Exclusion Criteria - All Groups
1. Participant has impaired decision-making capacity or is unable to provide informed
consent.
2. Participant has undergone partial or complete hysterectomy including removal of the
cervix.
3. Participant on whom any form of cervical tissue alteration or surgery has been
performed within the prior < 5 months, including: conization, loop electrosurgical
excision procedure (LEEP), laser ablative surgery, or cryotherapy.
4. Participant is pregnant (based on self-reporting).
5. Participant who reports or is experiencing menstrual bleeding.
6. Participant 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.
7. Any medical reason that, in the investigator's judgment, would disqualify the
participant for a routine pelvic exam with cervical sample collection.
Gender:
Female
Minimum age:
25 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Birmingham OBGYN / Alabama Clinical Therapeutics
Address:
City:
Birmingham
Zip:
35235
Country:
United States
Facility:
Name:
Planned Parenthood Arizona
Address:
City:
Tucson
Zip:
85712
Country:
United States
Facility:
Name:
Planned Parenthood Northern California
Address:
City:
San Francisco
Zip:
94109
Country:
United States
Facility:
Name:
University of Colorado Anschutz Medical Campus
Address:
City:
Aurora
Zip:
80045
Country:
United States
Facility:
Name:
Planned Parenthood Southern New England
Address:
City:
New Haven
Zip:
06511
Country:
United States
Facility:
Name:
Yale University
Address:
City:
New Haven
Zip:
06520
Country:
United States
Facility:
Name:
Woman's Hospital
Address:
City:
Baton Rouge
Zip:
70817
Country:
United States
Facility:
Name:
Johns Hopkins University
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Facility:
Name:
Planned Parenthood League of Massachusetts
Address:
City:
Boston
Zip:
02215
Country:
United States
Facility:
Name:
Planned Parenthood St. Louis Region
Address:
City:
Saint Louis
Zip:
62208
Country:
United States
Facility:
Name:
Washington University
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Facility:
Name:
New York University Langone Hospital
Address:
City:
Mineola
Zip:
11501
Country:
United States
Facility:
Name:
Unified Women's Clinical Research Raleigh
Address:
City:
Raleigh
Zip:
27607
Country:
United States
Facility:
Name:
Unified Women's Clinical Research - Lyndhurst
Address:
City:
Winston-Salem
Zip:
27103
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:
November 15, 2023
Completion date:
June 1, 2024
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/NCT06120205
