Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions

Recruiting

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

• Registration Number: NCT04219605
• Lead Sponsor: Meir Medical Center

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2020-01-05
• Study First Submitted QC: 2020-01-05
• Study First Posted: 2020-01-07
• Study Start: 2020-12-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-21
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

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

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic performance	12 months	Specificity and sensitivity of the device performance in regard to vaginitis conditions

Trial Locations

Locations (1)

Clalit HMO; 🇮🇱 Jerusalem, Israel