Gyni™ Study With Leumit Health Services
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Symptomatic vaginitis patients All participants will be enrolled according to their complaints, All will be tested by the Gyni system, Only in the second group the physician will be unblinded to the Gyni results. |
Diagnostic Test: Gyni
Vaginal discharge collection
|
Outcome Measures
Primary Outcome Measures
- Comparison parameter [12 months]
Number of visits (from initial visit until the cause of vaginitis is detected)
- Comparison parameter [12 months]
Total cost of medication
- Comparison parameter [12 months]
Total Cost of lab tests
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female ≥18 years old
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Able to read, understand and sign an informed consent form
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At least one of the following: abnormal vaginal discharge, odor, vulvovaginal itch, burning, irritation, dyspareunia, vaginal dryness or pain.
Exclusion Criteria:
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Patients under the age of 18 years
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Patient is unfit to provide an informed consent
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Patient with vaginal bleeding, including menstruation within past 24 hours21
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Patient who used intra vaginal preparations within 72 hours prior to study enrollment (antimicrobials, spermicides, lubricants, diaphragm)22
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Uninterpretable sample (e.g. patients who used vaginal creams or lubricants before the visit or insufficient sampling material)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Netanya Women's health center, Leumit Health services (HMO) | Netanya | Central | Israel | 4240200 |
2 | Kfar Yasif clinic | Kfar Yasif | North | Israel | 2490800 |
3 | Kiryat Bialik, Leumit health services (HMO) Women's health clinic | Kiryat Bialik | North | Israel | 2709325 |
4 | Leumit women's health | Jerusalem | Israel | 9439000 |
Sponsors and Collaborators
- GynTools Ltd.
- Leumit Health Services
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CL00000-16