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Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device

Archive of Vaginal Swabs Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03585049
Enrollment
500
Registered
2018-07-12
Start date
2018-10-01
Completion date
2022-12-01
Last updated
2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginitis

Brief summary

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

Detailed 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.

Interventions

The protocol includes the secondary use of vaginal swabs that are primarily used for routine diagnostic assessment in a vulvovaginal clinic

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Vulvovaginal complaints

Exclusion criteria

Younger than 18y or cannot sign an informed consent form

Design outcomes

Primary

MeasureTime frameDescription
Creation of microscopy image archive1 yearCollecting 1000 images

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026