At a glance
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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
In Brief
A clinical study evaluating Self sampling kit for collecting discharge from vaginal fornix for Human Papillomavirus Infection and 2 related conditions. Completed, enrolled 1,210 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort.