← Back to Search

Device

Self-Screening Device for Cervical Cancer

N/A

Waitlist Available

Led By Megan Fitzpatrick, MD

Research Sponsored by Teal Health, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days

Awards & highlights

Study Summary

This trial tests a new way to screen for cervical cancer, without a doctor's visit.

Who is the study for?

This trial is for women aged 25 to 65 with an intact cervix who can consent. It's open to those without current menstruation, not pregnant, and haven't used certain cervical products recently. Women with a history of high-risk HPV or abnormal cytology results are also eligible.Check my eligibility

What is being tested?

The study is testing a new self-collection device by Teal Health for cervical cancer screening. Participants will use the device themselves to collect samples that will be evaluated for effectiveness in detecting potential cancer indicators.See study design

What are the potential side effects?

Since this trial involves a non-invasive collection device, side effects may be minimal but could include discomfort or slight bleeding during or after sample collection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ acute - immediately after self-collection procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~acute - immediately after self-collection procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and acute - immediately after self-collection procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Effectiveness: Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)

Primary Effectiveness: Sample Inadequacy Rate

Primary Safety: SAEs

Secondary outcome measures

Rate of sample adequacy for liquid-based cytology analysis

Satisfaction and Needs Survey

Usability Survey

Trial Design

1Treatment groups

Experimental Treatment

Group I: Teal Health Self-Collection Device GroupExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Teal Health, Inc.Lead Sponsor

1 Previous Clinical Trials

870 Total Patients Enrolled

Megan Fitzpatrick, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there restrictions on the age of candidates for this trial?

"The age range for this study is limited to adults aged 25 and over, up until the maximum of 65 years."

Answered by AI

How many sites are executing this research endeavor?

"Several medical centres are running this trial, including Boston Metro in Westwood, Massachusetts; Planned Parenthood Gulf Coast in Houston, Texas; and the University of Wisconsin - Madison in Madison."

Answered by AI

Does this experiment offer ongoing recruitment opportunities?

"According to clinicaltrials.gov, the initial posting date for this research study was August 28th 2022 and it was last updated on December 19th 2022. Unfortunately, there are no current opportunities available through this trial; however, 1171 other studies are presently enrolling patients."

Answered by AI

Is the opportunity available to join this research endeavor?

"Aspiring enrollees of this clinical trial must be between the ages 25 and 65, as well as suffer from a human papilloma virus infection. The total number of participants is expected to reach 150 in due course."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Development of a Self-collection Device for Cervical Cancer Screening

2022. "Development of a Self-collection Device for Cervical Cancer Screening". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05669911.

All > Cervical Cancer