Gyni™ Study With Leumit Health Services

Gyni™ System Pilot Study With Leumit Health Services - Prospective Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04816903

Enrollment

600

Registered

2021-03-25

Start date

2021-03-07

Completion date

2022-03-07

Last updated

2021-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginitis

Keywords

gynecology, IVD

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.

Interventions

DIAGNOSTIC_TESTGyni

Vaginal discharge collection

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Group-A Blinded Group-B Unblinded

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 99 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Comparison parameter	12 months	Number of visits (from initial visit until the cause of vaginitis is detected)

Countries

Israel

Contacts

Primary ContactYardenna Glader

yardenna@gyntools.com+972525522116

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026