Back to resultsGyni™ Study With Leumit Health Services
Primary Purpose
Vaginitis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Gyni
Sponsored by
About this trial
This is an interventional diagnostic trial for Vaginitis focused on measuring gynecology, IVD
Eligibility 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)
Sites / Locations
- Netanya Women's health center, Leumit Health services (HMO)
- Kfar Yasif clinicRecruiting
- Kiryat Bialik, Leumit health services (HMO) Women's health clinic
- Leumit women's healthRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Symptomatic vaginitis patients
Arm Description
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.
Outcomes
Primary Outcome Measures
Comparison parameter
Number of visits (from initial visit until the cause of vaginitis is detected)
Comparison parameter
Total cost of medication
Comparison parameter
Total Cost of lab tests
Secondary Outcome Measures
Full Information
NCT ID
NCT04816903
First Posted
March 22, 2021
Last Updated
March 24, 2021
Sponsor
GynTools Ltd.
Collaborators
Leumit Health Services
1. Study Identification
Unique Protocol Identification Number
NCT04816903
Brief Title
Gyni™ Study With Leumit Health Services
Official Title
Gyni™ System Pilot Study With Leumit Health Services - Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 7, 2021 (Actual)
Primary Completion Date
March 7, 2022 (Anticipated)
Study Completion Date
March 7, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GynTools Ltd.
Collaborators
Leumit Health Services
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginitis
Keywords
gynecology, IVD
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Group-A Blinded Group-B Unblinded
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Symptomatic vaginitis patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Gyni
Intervention Description
Vaginal discharge collection
Primary Outcome Measure Information:
Title
Comparison parameter
Description
Number of visits (from initial visit until the cause of vaginitis is detected)
Time Frame
12 months
Title
Comparison parameter
Description
Total cost of medication
Time Frame
12 months
Title
Comparison parameter
Description
Total Cost of lab tests
Time Frame
12 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yardenna Glader
Phone
+972525522116
Email
yardenna@gyntools.com
Facility Information:
Facility Name
Netanya Women's health center, Leumit Health services (HMO)
City
Netanya
State/Province
Central
ZIP/Postal Code
4240200
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir L Weintraub, MD
Phone
+972508685330
Facility Name
Kfar Yasif clinic
City
Kfar Yasif
State/Province
North
ZIP/Postal Code
2490800
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marwan Odeh, MD
Phone
972507887486
Facility Name
Kiryat Bialik, Leumit health services (HMO) Women's health clinic
City
Kiryat Bialik
State/Province
North
ZIP/Postal Code
2709325
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lior Lowenstein, Professor
Phone
972502061434
Facility Name
Leumit women's health
City
Jerusalem
ZIP/Postal Code
9439000
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avishai Malkiel, MD
Phone
972587424564
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gyni™ Study With Leumit Health Services
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