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NCT04219605 Clinical Trial

Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions

Bacterial Vaginosis Clinical Trial

Official title:
Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04219605
Other study ID # 0120-19-COM1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date December 2023

Study information
Verified date March 2023
Source Meir Medical Center
Contact Ahinoam Lev-Sagie, MD
Phone 972-2-5889551
Email levsagie@netvision.net.il
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Clalit HMO Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic performance Specificity and sensitivity of the device performance in regard to vaginitis conditions 12 months
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