Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device

Completed

• Conditions: Vaginitis

• Registration Number: NCT03585049
• Lead Sponsor: Meir Medical Center

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.

Study Timeline

• Study First Submitted: 2018-06-30
• Study First Submitted QC: 2018-06-30
• Study First Posted: 2018-07-12
• Study Start: 2018-10-01
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

Vulvovaginal complaints

Exclusion Criteria

Younger than 18y or cannot sign an informed consent form

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Creation of microscopy image archive	1 year	Collecting 1000 images

Trial Locations

Locations (1)

Clalit Women's Health Center; 🇮🇱 Jerusalem, Israel