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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

Study 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.Check my eligibility

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.See study design

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

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

Primary outcome measures

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

Safety: SAE rate

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

Find a Location

Who is running the clinical trial?

Teal Health, Inc.Lead Sponsor

1 Previous Clinical Trials

235 Total Patients Enrolled

Frequently Asked Questions

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

At how many venues is this research endeavor taking place?

"Potential participants of this medical trial have 13 different sites to choose from, such as Planned Parenthood Arizona in Tucson, Planned Parenthood Northern California in San Francisco and the University of Colorado Anschutz Medical Campus in Aurora."

Answered by AI

Is it possible for me to sign up as a participant in this research?

"A prerequisite for joining this medical trial is that patients have human papillomavirus and are aged between 25-65. The study aims to include 870 participants in total."

Answered by AI

Is there ongoing recruitment for this experiment?

"Clinicaltrials.gov states that this particular trial is not currently recruiting participants; it was initially published on November 6th, 2023 and last edited on the 1st of same month. Nevertheless, there are 1174 clinical trials open for enrollment at present."

Answered by AI

Is the age restriction for this research initiative 25 and above?

"According to the specified inclusion criteria, this clinical trial is seeking participants aged 25-65. There are separate trials for patients younger than 18 and those above 65 years of age; 224 in total and 948 respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening

2023. "SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06120205.

All > Hpv > Cervical Cancer