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| Name | Class |
|---|---|
| Leumit Health Services | OTHER |
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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 Gyniâ„¢ system is intended to provide physicians with the means to obtain an accurate, fast and inexpensive diagnosis which is unavailable today.
Gyniâ„¢ 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 Gyniâ„¢ by comparing its usage outcomes in a practice setting to the outcomes obtained using the current standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic vaginitis patients | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gyni | Diagnostic Test | Vaginal discharge collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison parameter | Number of visits (from initial visit until the cause of vaginitis is detected) | 12 months |
| Comparison parameter | Total cost of medication | 12 months |
| Comparison parameter | Total Cost of lab tests | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Females
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yardenna Glader | Contact | +972525522116 | yardenna@gyntools.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netanya Women's health center, Leumit Health services (HMO) | Not yet recruiting | Netanya | Central District | 4240200 | Israel |
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| ID | Term |
|---|---|
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Group-A Blinded Group-B Unblinded
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| Kfar Yasif clinic | Recruiting | Kfar Yasif | North | 2490800 | Israel |
|
| Kiryat Bialik, Leumit health services (HMO) Women's health clinic | Not yet recruiting | Kiryat Bialik | North | 2709325 | Israel |
|
| Leumit women's health | Recruiting | Jerusalem | 9439000 | Israel |
|
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |