Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
600 participants
INTERVENTIONAL
2021-03-07
2022-03-07
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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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.
Gyni
Vaginal discharge collection
Interventions
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Gyni
Vaginal discharge collection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
99 Years
FEMALE
No
Sponsors
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Leumit Health Services
OTHER
GynTools Ltd.
INDUSTRY
Responsible Party
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Locations
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Netanya Women's health center, Leumit Health services (HMO)
Netanya, Central District, Israel
Kfar Yasif clinic
Kfar Yasif, North, Israel
Kiryat Bialik, Leumit health services (HMO) Women's health clinic
Kiryat Bialik, North, Israel
Leumit women's health
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Amir L Weintraub, MD
Role: primary
Marwan Odeh, MD
Role: primary
Lior Lowenstein, Professor
Role: primary
Avishai Malkiel, MD
Role: primary
Other Identifiers
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CL00000-16
Identifier Type: -
Identifier Source: org_study_id
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