About one third of the women referring to gynecological clinics present with vulvovaginal inflammation symptoms (vaginitis) possibly caused by seven different conditions or mixed infections. The Gyni™ system is intended to provide physicians with the means to obtain an accurate, fast and inexpensive diagnosis which is unavailable today. Gyni™ is comprised of a compact tabletop scanner, a disposable sample collector and a cloud based algorithm that provides a suggested diagnosis within 5 minutes. The trial is a prospective evaluation of the cost-effectiveness of using Gyni™ by comparing its usage outcomes in a practice setting to the outcomes obtained using the current standard of care.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
600
Vaginal discharge collection
Netanya Women's health center, Leumit Health services (HMO)
Netanya, Central District, Israel
NOT_YET_RECRUITINGKfar Yasif clinic
Kfar Yasif, North, Israel
RECRUITINGKiryat Bialik, Leumit health services (HMO) Women's health clinic
Kiryat Bialik, North, Israel
NOT_YET_RECRUITINGComparison parameter
Number of visits (from initial visit until the cause of vaginitis is detected)
Time frame: 12 months
Comparison parameter
Total cost of medication
Time frame: 12 months
Comparison parameter
Total Cost of lab tests
Time frame: 12 months
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Leumit women's health
Jerusalem, Israel
RECRUITING