Gyni™ Study With Leumit Health Services

Gyni™ System Pilot Study With Leumit Health Services - Prospective Study

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.

Inclusion Criteria:

• Female ≥18 years old
• Able to read, understand and sign an informed consent form
• At least one of the following: abnormal vaginal discharge, odor, vulvovaginal itch, burning, irritation, dyspareunia, vaginal dryness or pain.

Exclusion Criteria:

• Patients under the age of 18 years
• Patient is unfit to provide an informed consent
• Patient with vaginal bleeding, including menstruation within past 24 hours21
• Patient who used intra vaginal preparations within 72 hours prior to study enrollment (antimicrobials, spermicides, lubricants, diaphragm)22
• Uninterpretable sample (e.g. patients who used vaginal creams or lubricants before the visit or insufficient sampling material)