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NCT03585049 Clinical Trial

Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device

Vaginitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03585049
Other study ID # 077-18-COM1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date December 1, 2022

Study information
Verified date March 2023
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: Vulvovaginal complaints Exclusion Criteria: Younger than 18y or cannot sign an informed consent form

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Israel Clalit Women's Health Center Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Creation of microscopy image archive Collecting 1000 images 1 year
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