Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate the diagnostic performance of the Gyniâ„¢ device to detect different vaginitis conditions by comparison to microscopic diagnosis and related lab tests.
During gynecological exams, vaginal discharge samples will be are taken for testing the pH level, microscopic examination and laboratory examinations (vaginal cultures and sexually transmitted infections).
One additional sample will be taken intended for the Gyniâ„¢ system diagnosis. This additional examination will be performed in the clinic by pulling the cytobrush through a dedicated cartridge and scanning it in the Gyni table-top scanner. The result diagnosis will be anonymously kept in the cloud.
The diagnosis suggested by the Gyni system will not be visible to the physician in order to prevent any bias. Results from the physician, from the device and from the lab will be summarized and compared by the chief investigator
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic vaginitis patients | Symptomatic patients evaluated in the clinic for vulvovaginal symptoms. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance | Specificity and sensitivity of the device performance in regard to vaginitis conditions | 12 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
The study examine a diagnostic test for vaginal inflammations (vaginitis) which is only applicable to female patients.
Not provided
Patients with vulvovaginal symptoms
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Avraham Ben Chetrit, MD | Clalit HMO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clalit HMO | Jerusalem | Jerusalem | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37055473 | Background | Lev-Sagie A, Strauss D, Ben Chetrit A. Diagnostic performance of an automated microscopy and pH test for diagnosis of vaginitis. NPJ Digit Med. 2023 Apr 13;6(1):66. doi: 10.1038/s41746-023-00815-w. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| D002181 | Candidiasis, Vulvovaginal |
| D014247 | Trichomonas Vaginitis |
| D059268 | Atrophic Vaginitis |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
Not provided
Not provided
Not provided
Not provided
Not provided
| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D014848 | Vulvovaginitis |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D014245 | Trichomonas Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |