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Gyni™ Study With Leumit Health Services

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ClinicalTrials.gov Identifier: NCT04816903
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : March 25, 2021
Sponsor:
Collaborator:
Leumit Health Services
Information provided by (Responsible Party):
GynTools Ltd.

Study Description
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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
Vaginitis Diagnostic Test: Gyni Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Group-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 : March 7, 2021
Estimated Primary Completion Date : March 7, 2022
Estimated Study Completion Date : March 7, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Comparison parameter [ Time Frame: 12 months ]
    Number of visits (from initial visit until the cause of vaginitis is detected)

  2. Comparison parameter [ Time Frame: 12 months ]
    Total cost of medication

  3. Comparison parameter [ Time Frame: 12 months ]
    Total Cost of lab tests


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816903


Contacts
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Contact: Yardenna Glader +972525522116 yardenna@gyntools.com

Locations
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Israel
Netanya Women's health center, Leumit Health services (HMO) Not yet recruiting
Netanya, Central, Israel, 4240200
Contact: Amir L Weintraub, MD    +972508685330      
Kfar Yasif clinic Recruiting
Kfar Yasif, North, Israel, 2490800
Contact: Marwan Odeh, MD    972507887486      
Kiryat Bialik, Leumit health services (HMO) Women's health clinic Not yet recruiting
Kiryat Bialik, North, Israel, 2709325
Contact: Lior Lowenstein, Professor    972502061434      
Leumit women's health Recruiting
Jerusalem, Israel, 9439000
Contact: Avishai Malkiel, MD    972587424564      
Sponsors and Collaborators
GynTools Ltd.
Leumit Health Services
More Information
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Responsible Party: GynTools Ltd.
ClinicalTrials.gov Identifier: NCT04816903    
Other Study ID Numbers: CL00000-16
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.:
gynecology
IVD
Additional relevant MeSH terms:
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Vaginitis
Vaginal Diseases