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Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions

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: NCT04219605
Recruitment Status : Not yet recruiting
First Posted : January 7, 2020
Last Update Posted : January 7, 2020
GynTools Ltd.
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:
Evaluate the diagnostic performance of the Gyni™ device to detect different vaginitis conditions by comparison to microscopic diagnosis and related lab tests.

Condition or disease
Bacterial Vaginosis Candida Albicans Vulvovaginitis Candida Non Albicans Vulvovaginitis Trichomonas Vaginitis Atrophic Vaginitis Desquamative Inflammatory Vaginitis

Detailed Description:

During gynecological exams, vaginal discharge samples will be are taken for testing the pH level, microscopic examination and laboratory examinations (vaginal cultures and sexually transmitted infections).

One additional sample will be taken intended for the Gyni™ system diagnosis. This additional examination will be performed in the clinic by pulling the cytobrush through a dedicated cartridge and scanning it in the Gyni table-top scanner. The result diagnosis will be anonymously kept in the cloud.

The diagnosis suggested by the Gyni system will not be visible to the physician in order to prevent any bias. Results from the physician, from the device and from the lab will be summarized and compared by the chief investigator

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis

Symptomatic vaginitis patients
Symptomatic patients evaluated in the clinic for vulvovaginal symptoms.

Primary Outcome Measures :
  1. Diagnostic performance [ Time Frame: 12 months ]
    Specificity and sensitivity of the device performance in regard to vaginitis conditions

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
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study examine a diagnostic test for vaginal inflammations (vaginitis) which is only applicable to female patients.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with vulvovaginal symptoms

Inclusion Criteria:

Women with vaginal complaints: Discharge, Malodor, Itching, Irritation, Dyspareunia, Pain Age >= 18y

Exclusion Criteria:

Age < 18y Not eligible to sign an informed consent Vaginal discharge samples found microscopically not interpret-able by the investigator due to patient using vaginal creams, ointments, lubricants or sperm presence.

During menstruation

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): NCT04219605

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Contact: Ahinoam Lev-Sagie, MD 972-2-5889551

Sponsors and Collaborators
Meir Medical Center
GynTools Ltd.
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Responsible Party: Meir Medical Center Identifier: NCT04219605    
Other Study ID Numbers: 0120-19-COM1
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Candidiasis, Vulvovaginal
Trichomonas Vaginitis
Atrophic Vaginitis
Vaginal Diseases
Bacterial Infections
Trichomonas Infections
Protozoan Infections
Parasitic Diseases
Vulvar Diseases