Status:
UNKNOWN
Gyni™ Study With Leumit Health Services
Lead Sponsor:
GynTools Ltd.
Collaborating Sponsors:
Leumit Health Services
Conditions:
Vaginitis
Eligibility:
FEMALE
18-99 years
Phase:
NA
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™...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 7 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04816903
Start Date
March 7 2021
End Date
March 7 2022
Last Update
March 25 2021
Active Locations (4)
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1
Netanya Women's health center, Leumit Health services (HMO)
Netanya, Central District, 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