Agreement of hrHPV Type Between Self-collected Sample From Vaginal Fornix and Physician Collected Sample From the Cervical Surface

Human Papillomavirus Infection Clinical Trial

Official title: Evaluate the Agreement of High-risk Human Papillomavirus Type Between Self-collected Vaginal Discharge Sample Using "HygeiaTouch Self Sampling Kit for Woman" and Physician Collected Sample From the Cervix

Status Completed

Clinical Trial 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.

Clinical Trial Description

Primary end-point:

1. Agreement of hr-HPV types, including types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, between the physician-collected sample and self-collected sample

2. Agreement of the presence of hr-HPV between the physician-collected sample and self-collected sample

Secondary end-point:

1. Percentage of the valid sample between self-collected and physician-collected specimens

2. Agreement of all (N = 27) HPV types between the paired samples

3. Adverse events associated with sample collection

4. Questionnaire of the appreciation and satisfaction of using self-collecting vaginal discharge sample using "Hygeia Touch Self Sampling Kit for Women" through a short movie and a brief illustration

5. Correlation between histological diagnosis and HPV types ;

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections
• Self Sampling
• Vaginal Discharge

• NCT number: NCT04472377
• Study type: Interventional
• Source: Hygeia Touch Inc.
• Status: Completed
• Phase: N/A
• Start date: May 29, 2020
• Completion date: April 18, 2022