Gyni™ Study With Leumit Health Services

Not Applicable

• Conditions: Vaginitis
• Interventions: Diagnostic Test: Gyni

• Registration Number: NCT04816903
• Lead Sponsor: GynTools Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-07
• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-24
• Last Update Submitted: 2021-03-24
• Study First Posted: 2021-03-25
• Last Update Posted: 2021-03-25
• Primary Completion: 2022-03-07
• Study Completion: 2022-03-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Symptomatic vaginitis patients	Gyni	All participants will be enrolled according to their complaints, All will be tested by the Gyni system, Only in the second group the physician will be unblinded to the Gyni results.

Primary Outcome Measures

Name	Time	Method
Comparison parameter	12 months	Total Cost of lab tests

Trial Locations

Locations (4)

Netanya Women's health center, Leumit Health services (HMO); 🇮🇱 Netanya, Central, 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