Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

226 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-03-30

Brief Summary

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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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Detailed Description

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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

Conditions

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Bacterial Vaginosis Candida Albicans Vulvovaginitis Candida Vulvovaginitis Trichomonas Vaginitis Atrophic Vaginitis Desquamative Inflammatory Vaginitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Symptomatic vaginitis patients

Symptomatic patients evaluated in the clinic for vulvovaginal symptoms.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No