Gyni™ Study With Leumit Health Services

Sponsor
GynTools Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04816903
Collaborator
Leumit Health Services (Other)
600
4
1
12
150
12.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Gyni
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Group-A Blinded Group-B UnblindedGroup-A Blinded Group-B Unblinded
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Gyni™ System Pilot Study With Leumit Health Services - Prospective Study
Actual Study Start Date :
Mar 7, 2021
Anticipated Primary Completion Date :
Mar 7, 2022
Anticipated Study Completion Date :
Mar 7, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Comparison parameter [12 months]

    Number of visits (from initial visit until the cause of vaginitis is detected)

  2. Comparison parameter [12 months]

    Total cost of medication

  3. Comparison parameter [12 months]

    Total Cost of lab tests

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Netanya Women's health center, Leumit Health services (HMO) Netanya Central Israel 4240200
2 Kfar Yasif clinic Kfar Yasif North Israel 2490800
3 Kiryat Bialik, Leumit health services (HMO) Women's health clinic Kiryat Bialik North Israel 2709325
4 Leumit women's health Jerusalem Israel 9439000

Sponsors and Collaborators

  • GynTools Ltd.
  • Leumit Health Services

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GynTools Ltd.
ClinicalTrials.gov Identifier:
NCT04816903
Other Study ID Numbers:
  • CL00000-16
First Posted:
Mar 25, 2021
Last Update Posted:
Mar 25, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by GynTools Ltd.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 25, 2021