Gyni™ Study With Leumit Health Services

Last updated: March 24, 2021
Sponsor: GynTools Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaginitis

Treatment

N/A

Clinical Study ID

NCT04816903
CL00000-16
  • Ages 18-99
  • Female

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.

Eligibility Criteria

Inclusion

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

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 thevisit or insufficient sampling material)

Study Design

Total Participants: 600
Study Start date:
March 07, 2021
Estimated Completion Date:
March 07, 2022

Connect with a study center

  • Netanya Women's health center, Leumit Health services (HMO)

    Netanya, Central 4240200
    Israel

    Site Not Available

  • Kfar Yasif clinic

    Kfar Yasif, North 2490800
    Israel

    Active - Recruiting

  • Kiryat Bialik, Leumit health services (HMO) Women's health clinic

    Kiryat Bialik, North 2709325
    Israel

    Site Not Available

  • Leumit women's health

    Jerusalem, 9439000
    Israel

    Active - Recruiting

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