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

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

Study Overview

• Status: Completed
• Conditions: Vaginitis
• Intervention / Treatment: Other: Vaginal swabs

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 Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Clalit Women's Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All patients above 18y that go through a routine vulvovaginal assessment at the clinic

Description

Inclusion Criteria:

Vulvovaginal complaints

Exclusion Criteria:

Younger than 18y or cannot sign an informed consent form

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creation of microscopy image archive	Collecting 1000 images	1 year

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Principal Investigator: Ahinoam LevSagie, M.D., Clalit Healthcare Services

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: June 30, 2018
• First Submitted That Met QC Criteria: June 30, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vaginal Diseases; Vaginitis
• Other Study ID Numbers: 077-18-COM1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be collected except for consent forms which will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No