Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device
NCT ID: NCT03585049
Last Updated: 2023-03-15
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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COMPLETED
500 participants
OBSERVATIONAL
2018-10-01
2022-12-01
Brief Summary
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Detailed Description
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In order to create an anonymous archive of digital microscopy images, before each swab is disposed of, the investigator will dilute the collected discharge on the swab with 0.5ml Saline into an Eppendorf tube. The diluted discharge will then be applied onto the GynTools LTD VagX tray that is then scanned by a tabletop scanner. At this point the VagX tray will be washed with water, soap and both the swab and tube will be disposed of.
No of participating patients: 1000 Patients age: 18 years and above. Only from patients capable of signing an informed consent.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Vaginal swabs
The protocol includes the secondary use of vaginal swabs that are primarily used for routine diagnostic assessment in a vulvovaginal clinic
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Meir Medical Center
OTHER
Responsible Party
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Ahinoam Lev-Sagie
Principal Investigator
Principal Investigators
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Ahinoam LevSagie, M.D.
Role: PRINCIPAL_INVESTIGATOR
Clalit Healthcare Services
Locations
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Clalit Women's Health Center
Jerusalem, , Israel
Countries
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Other Identifiers
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077-18-COM1
Identifier Type: -
Identifier Source: org_study_id
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