NCT03585049

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
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vaginitis

Interventions

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

Timeline

• Start date: 2018-10-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2018-07-12
• Last updated: 2023-03-15

Locations

1 site across 1 country: Israel