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

Completed

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Key information

Conditions

Vaginitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vaginal Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Clalit Women's Health Center

Jerusalem, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Vulvovaginal complaints

Exclusion criteria

Younger than 18y or cannot sign an informed consent form

Treatment and study plan

Vaginal swabs

Other

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

Primary outcomes

Creation of microscopy image archive

Time frame: 1 year

Collecting 1000 images

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Jul 12, 2018
Registry last updated: Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed