Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions
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|ClinicalTrials.gov Identifier: NCT04219605|
Recruitment Status : Not yet recruiting
First Posted : January 7, 2020
Last Update Posted : January 7, 2020
|Condition or disease|
|Bacterial Vaginosis Candida Albicans Vulvovaginitis Candida Non Albicans Vulvovaginitis Trichomonas Vaginitis Atrophic Vaginitis Desquamative Inflammatory Vaginitis|
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 Gyni™ 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
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Symptomatic vaginitis patients
Symptomatic patients evaluated in the clinic for vulvovaginal symptoms.
- Diagnostic performance [ Time Frame: 12 months ]Specificity and sensitivity of the device performance in regard to vaginitis conditions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04219605
|Contact: Ahinoam Lev-Sagie, MDemail@example.com|