Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device

Sponsor

Meir Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03585049

Collaborator

(none)

1,000

Enrollment

Location

Anticipated Duration (Months)

16.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vaginitis	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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

Creation of microscopy image archive [1 year]
Collecting 1000 images

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Vulvovaginal complaints

Exclusion Criteria:

Younger than 18y or cannot sign an informed consent form

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clalit Women's Health Center	Jerusalem		Israel

Sponsors and Collaborators

Meir Medical Center

Investigators

Principal Investigator: Ahinoam LevSagie, M.D., Clalit Healthcare Services

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahinoam Lev-Sagie, Principal Investigator, Meir Medical Center

ClinicalTrials.gov Identifier:

NCT03585049

Other Study ID Numbers:

077-18-COM1

First Posted:

Jul 12, 2018

Last Update Posted:

Apr 8, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vaginitis

Study Results

No Results Posted as of Apr 8, 2022