Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions

Sponsor

Meir Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04219605

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bacterial Vaginosis Candida Albicans Vulvovaginitis Candida Vulvovaginitis Trichomonas Vaginitis Atrophic Vaginitis Desquamative Inflammatory Vaginitis

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions

Actual Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Symptomatic vaginitis patients Symptomatic patients evaluated in the clinic for vulvovaginal symptoms.

Outcome Measures

Primary Outcome Measures

Diagnostic performance [12 months]
Specificity and sensitivity of the device performance in regard to vaginitis conditions

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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