Gyni™ Study With Leumit Health Services

GynTools

Status: Unknown

Conditions: Vaginitis

Treatments: Diagnostic Test: Gyni

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04816903

CL00000-16

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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600 participants in 1 patient group

Symptomatic vaginitis patients

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Gyni