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Gyni™ Study With Leumit Health Services

NCT04816903 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2021-03-25

No results posted yet for this study

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.

Conditions

  • Vaginitis

Interventions

DIAGNOSTIC_TEST

Gyni

Vaginal discharge collection

Sponsors & Collaborators

  • Leumit Health Services

    collaborator OTHER

  • GynTools Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-07
Primary Completion
2022-03-07
Completion
2022-03-07

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04816903 on ClinicalTrials.gov