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Validation of Vaginal Self-Sampling With the Abbott Multi-Collect Swab for HPV Screening in Women Aged 30 to 64 Years

NCT07768787 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-08-17

No results posted yet for this study

Summary

This study evaluates the performance of HPV testing on vaginal self-collected samples obtained with the Abbott Multi-Collect device. The study compares HPV test results from self-collected vaginal samples with results from clinician-collected cervical samples in women aged 30 to 64 years who either participate regularly in cervical cancer screening or have not attended screening for at least 3 years. The goal is to determine whether self-sampling provides accurate detection of high-risk human papillomavirus (hrHPV) and could support broader participation in cervical cancer screening programs.

Conditions

Interventions

DEVICE

Abbott Multi-Collect Specimen Collection Swab

Vaginal self-sampling device used for collection of self-collected vaginal specimens for high-risk human papillomavirus testing.

Sponsors & Collaborators

  • AML

    lead INDUSTRY

Eligibility

Min Age
30 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-19
Primary Completion
2026-07-06
Completion
2026-07-31
FDA Device
Yes

Countries

  • Belgium

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 NCT07768787 on ClinicalTrials.gov