Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions

Clalit Health Services

Status: Completed

Conditions: Atrophic Vaginitis; Candida Albicans Vulvovaginitis; Bacterial Vaginosis; Trichomonas Vaginitis; Desquamative Inflammatory Vaginitis; Candida Vulvovaginitis

Study type: Observational

Funder types: Other

Identifiers

NCT04219605

0120-19-COM1

Details and patient eligibility

About

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

Full 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

Enrollment: 226 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

226 participants in 1 patient group

Symptomatic vaginitis patients

Description:

Symptomatic patients evaluated in the clinic for vulvovaginal symptoms.