Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 500
Vulvovaginal complaints
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clalit Women's Health Center
🇮🇱Jerusalem, Israel