Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions

  • STATUS
    Recruiting
  • End date
    Dec 24, 2022
  • participants needed
    200
  • sponsor
    Meir Medical Center
Updated on 24 April 2022

Summary

Evaluate the diagnostic performance of the Gyni™ device to detect different vaginitis conditions by comparison to microscopic diagnosis and related lab tests.

Description

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

Details
Condition Bacterial Vaginosis, Candida Albicans Vulvovaginitis, Candida Vulvovaginitis, Trichomonas Vaginitis, Atrophic Vaginitis, Desquamative Inflammatory Vaginitis
Clinical Study IdentifierNCT04219605
SponsorMeir Medical Center
Last Modified on24 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Women with vaginal complaints: Discharge, Malodor, Itching, Irritation, Dyspareunia, Pain
Age >= 18y

Exclusion Criteria

Age < 18y
Not eligible to sign an informed consent
Vaginal discharge samples found microscopically not interpret-able by the investigator due to patient using vaginal creams, ointments, lubricants or sperm presence
During menstruation
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