Development of a Self-collection Device for Cervical Cancer Screening

NCT05669911 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2023-11-02

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

Teal Health Self-Collection Device Group

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.

Sponsors & Collaborators

  • Teal Health, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-28
Primary Completion
2023-11-06
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05669911 on ClinicalTrials.gov