NCT04472377

HPV Typing Between Self- and Physician-sampled

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,210 (actual)
• Sponsor: Hygeia Touch Inc. · Industry
• Sex: Female
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Human Papillomavirus Infection
• Self Sampling
• Vaginal Discharge

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-05-29
• Primary completion: 2021-12-21
• Completion: 2022-04-18
• First posted: 2020-07-15
• Last updated: 2024-10-03
• Results posted: 2024-08-12

Locations

3 sites across 1 country: Taiwan