Gyni™ Study With Leumit Health Services

March 24, 2021 updated by: GynTools Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel, 9439000
        • Recruiting
        • Leumit women's health
        • Contact:
          • Avishai Malkiel, MD
          • Phone Number: 972587424564
    • Central
      • Netanya, Central, Israel, 4240200
        • Not yet recruiting
        • Netanya Women's health center, Leumit Health services (HMO)
        • Contact:
          • Amir L Weintraub, MD
          • Phone Number: +972508685330
    • North
      • Kfar Yasif, North, Israel, 2490800
        • Recruiting
        • Kfar Yasif clinic
        • Contact:
          • Marwan Odeh, MD
          • Phone Number: 972507887486
      • Kiryat Bialik, North, Israel, 2709325
        • Not yet recruiting
        • Kiryat Bialik, Leumit health services (HMO) Women's health clinic
        • Contact:
          • Lior Lowenstein, Professor
          • Phone Number: 972502061434

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Symptomatic vaginitis patients
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.
Diagnostic test: Gyni
Vaginal discharge collection

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GynTools Ltd.

Collaborators

Leumit Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 7, 2021

Primary Completion (ANTICIPATED)

March 7, 2022

Study Completion (ANTICIPATED)

March 7, 2022

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (ACTUAL)

March 25, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 24, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL00000-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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