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Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device

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Clalit Health Services

Status

Completed

Conditions

Vaginitis

Treatments

Other: Vaginal swabs

Study type

Observational

Funder types

Other

Identifiers

NCT03585049
077-18-COM1

Details and patient eligibility

About

The study goal is to create an archive of microscopy images of various vulvovaginal inflammation conditions

Full description

During the study, the investigators are planning to make a secondary use of vaginal discharge samples that are primarily taken for routine wet mount microscopic diagnostics in a vulvovaginal clinic at the Women's health center, Ramat-Eshkol, Jerusalem.

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.

Enrollment

500 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Vulvovaginal complaints

Exclusion criteria

Younger than 18y or cannot sign an informed consent form

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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