Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions

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

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Key information

Conditions

Bacterial Vaginosis Atrophic Vaginitis Bacterial Infections Bacterial Infections and Mycoses Candida Albicans Vulvovaginitis Candida Vulvovaginitis Candidiasis Candidiasis, Vulvovaginal Desquamative Inflammatory Vaginitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Parasitic Diseases Protozoan Infections Trichomonas Infections Trichomonas Vaginitis Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Clalit HMO

Jerusalem, Israel

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Diagnostic performance

Time frame: 12 months

Specificity and sensitivity of the device performance in regard to vaginitis conditions

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: Jan 7, 2020
Registry last updated: May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed