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NCT04816903 Clinical Trial

Gyni™ Study With Leumit Health Services

Vaginitis Clinical Trial

Official title:
Gyni™ System Pilot Study With Leumit Health Services - Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04816903
Other study ID # CL00000-16
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 7, 2021
Est. completion date March 7, 2022

Study information
Verified date March 2021
Source GynTools Ltd.
Contact Yardenna Glader
Phone +972525522116
Email yardenna@gyntools.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

About one third of the women referring to gynecological clinics present with vulvovaginal inflammation symptoms (vaginitis) possibly caused by seven different conditions or mixed infections. The Gyni™ system is intended to provide physicians with the means to obtain an accurate, fast and inexpensive diagnosis which is unavailable today. Gyni™ is comprised of a compact tabletop scanner, a disposable sample collector and a cloud based algorithm that provides a suggested diagnosis within 5 minutes. The trial is a prospective evaluation of the cost-effectiveness of using Gyni™ by comparing its usage outcomes in a practice setting to the outcomes obtained using the current standard of care.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date March 7, 2022
Est. primary completion date March 7, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Female =18 years old - Able to read, understand and sign an informed consent form - At least one of the following: abnormal vaginal discharge, odor, vulvovaginal itch, burning, irritation, dyspareunia, vaginal dryness or pain. Exclusion Criteria: - Patients under the age of 18 years - Patient is unfit to provide an informed consent - Patient with vaginal bleeding, including menstruation within past 24 hours21 - Patient who used intra vaginal preparations within 72 hours prior to study enrollment (antimicrobials, spermicides, lubricants, diaphragm)22 - Uninterpretable sample (e.g. patients who used vaginal creams or lubricants before the visit or insufficient sampling material)

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Gyni
Vaginal discharge collection

Locations
Country Name City State
Israel Leumit women's health Jerusalem
Israel Kfar Yasif clinic Kfar Yasif North
Israel Kiryat Bialik, Leumit health services (HMO) Women's health clinic Kiryat Bialik North
Israel Netanya Women's health center, Leumit Health services (HMO) Netanya Central

Sponsors (2)
Lead Sponsor Collaborator
GynTools Ltd. Leumit Health Services

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison parameter Number of visits (from initial visit until the cause of vaginitis is detected) 12 months
Primary Comparison parameter Total cost of medication 12 months
Primary Comparison parameter Total Cost of lab tests 12 months
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