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Screening With Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views

NCT06154239 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 617

Last updated 2025-07-31

No results posted yet for this study

Summary

Diagnostic trial comparing the diagnostic accuracy of the DAYE Diagnostic Tampon (DDT) with a vaginal swab (self-collected and clinician taken).

Conditions

Interventions

DEVICE

DAYE Diagnostic Tampon

The DAYE Diagnostic Tampon is a class A in vitro diagnostic device. It has CE certification (self-certified via a declaration of conformity, following the IVDR (EU) 2017/746). The DDT is constructed entirely from woven cotton and consists of an absorbent core wrapped in a protective sleeve. The DDT is loaded in an applicator to aid with insertion.

DIAGNOSTIC_TEST

Vaginal self-swab

A vaginal self-swab typically consists of a long, slender, and flexible stick or handle, often made of plastic or a similar material. At one end, there's a soft, absorbent tip made of cotton or synthetic material. This tip is designed to collect a sample from the vaginal walls or cervix.

DIAGNOSTIC_TEST

Clinician vaginal swab

A clinician vaginal swab is a medical tool used by healthcare professionals to collect samples from the vaginal canal for diagnostic purposes. It's typically a long, thin, and flexible instrument. At one end, there's a cotton, rayon, or synthetic tip designed to collect cells, discharge, or other materials from the vaginal walls, cervix, or other areas within the vaginal canal. The clinician swab is not taken in sub-study participants.

Sponsors & Collaborators

  • Lindus Health

    collaborator INDUSTRY

  • Anne's Day Ltd

    lead INDUSTRY

Principal Investigators

  • Luke Twelves · Lindus Health

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2025-07-18
Completion
2025-07-18

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT06154239 on ClinicalTrials.gov