Gyni™ Study With Leumit Health Services

NCT04816903 | Unknown DMC

• 1 other identifier: CL00000-16
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 4

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.

Conditions

Vaginitis

Keywords

gynecology; IVD

Outcome Measures

Primary Outcomes (3)

• Comparison parameter

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

  12 months

• Comparison parameter

  Total cost of medication

  12 months

• Comparison parameter

  Total Cost of lab tests

  12 months

Study Arms (1)

Symptomatic vaginitis patients

EXPERIMENTAL

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

Interventions

Gyni DIAGNOSTIC_TEST

Vaginal discharge collection

Symptomatic vaginitis patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• GynTools Ltd.: lead
• Leumit Health Services: collaborator

Study Sites (4)

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

Netanya, Central District, 4240200, Israel

NOT YET RECRUITING

Kfar Yasif clinic

Kfar Yasif, North, 2490800, Israel

RECRUITING

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

Kiryat Bialik, North, 2709325, Israel

NOT YET RECRUITING

Leumit women's health

Jerusalem, 9439000, Israel

RECRUITING

MeSH Terms

Conditions

Vaginitis

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Yardenna Glader

CONTACT

+972525522116; yardenna@gyntools.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Group-A Blinded Group-B Unblinded

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 25, 2021
• Study Start: March 7, 2021
• Primary Completion: March 7, 2022
• Study Completion: March 7, 2022
• Last Updated: March 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (4)