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Self-Sampling Device for Cervical Cancer Screening

N/A

Waitlist Available

Research Sponsored by Teal Health, Inc.

Eligibility Criteria Checklist

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

Must have

Participant has an intact cervix.

Participant is 25 to 65 years of age and willing to provide informed consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-14 days following collections

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare a self-collected sample to an HCP-collected sample to test for HPV, and measure usability and preference.

Who is the study for?

This trial is for women aged 25-65 with an intact cervix, who can consent to participate. It includes those previously diagnosed with high-risk HPV or abnormal Pap results within the last 6 months, and those undergoing certain cervical procedures.

What is being tested?

The study compares the effectiveness of a self-collection device called Teal Wand for detecting high-risk HPV (hrHPV) against samples collected by healthcare providers using standard HPV testing methods.

What are the potential side effects?

There are no direct side effects mentioned for using the Teal Wand Self-Collection device as it's a non-invasive sampling tool. However, discomfort or emotional distress during self-sampling could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have an intact cervix.

Select...

I am between 25 and 65 years old and agree to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-14 days following collections

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-14 days following collections

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-14 days following collections for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy: Detection of hrHPV in self-collect and clinician collect samples

Safety: SAE rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Self-Collection / Clinician CollectionExperimental Treatment1 Intervention

Patient serves as own comparator/control in this method comparison study where the investigational intervention is use of the self-collect device and the comparator is the standard of care clinician collection.

0 / 2Eligibility criteria met