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HPV Typing Between Self- and Physician-sampled

NCT04472377 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1210

Last updated 2024-10-03

Study results available
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Summary

Hygeia Touch Inc. developed a safe and comfortable vaginal self-sampling device "Hygeia Touch Self Sampling Kit for Women" to self-collect the vaginal discharge sample for high-risk Human Papillomavirus (hrHPV) detection.

This clinical trial aimed to evaluate the agreement of hrHPV detections between vaginal self-sampling using "Hygeia Touch Self Sampling Kit for Women" and physician sampling, and these results will be applied for TFDA registration approval.

Conditions

  • Human Papillomavirus Infection
  • Self Sampling
  • Vaginal Discharge

Interventions

DEVICE

Self sampling kit for collecting discharge from vaginal fornix

A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort.

Sponsors & Collaborators

  • Hygeia Touch Inc.

    lead INDUSTRY

Principal Investigators

  • Hung-Hsueh Chou, MBBS, VS · Chang Gung Memorial Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-05-29
Primary Completion
2021-12-21
Completion
2022-04-18

Countries

  • Taiwan

Study Locations

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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 NCT04472377 on ClinicalTrials.gov