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Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03585049
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : December 26, 2018
Information provided by (Responsible Party):
Ahinoam Lev-Sagie, Meir Medical Center

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

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated 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 : October 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis

Intervention Details:
  • Other: Vaginal swabs
    The protocol includes the secondary use of vaginal swabs that are primarily used for routine diagnostic assessment in a vulvovaginal clinic

Primary Outcome Measures :
  1. Creation of microscopy image archive [ Time Frame: 1 year ]
    Collecting 1000 images

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients above 18y that go through a routine vulvovaginal assessment at the clinic

Inclusion Criteria:

Vulvovaginal complaints

Exclusion Criteria:

Younger than 18y or cannot sign an informed consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03585049

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Contact: Ahinoam LevSagie, M.D. 089762666

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Clalit Women's Health Center Recruiting
Jerusalem, Israel
Contact: Ahinoam Lev Sagie, MD         
Sponsors and Collaborators
Meir Medical Center
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Principal Investigator: Ahinoam LevSagie, M.D. Clalit Healthcare Services
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Responsible Party: Ahinoam Lev-Sagie, Principal Investigator, Meir Medical Center Identifier: NCT03585049    
Other Study ID Numbers: 077-18-COM1
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: December 26, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be collected except for consent forms which will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vaginal Diseases
Genital Diseases, Female