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Clinical Trials/NCT04219605
NCT04219605CompletedNot Applicable

Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions

Meir Medical Center1 site in 1 country226 target enrollmentStarted: December 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
226
Locations
1
Primary Endpoint
Diagnostic performance

Study Overview

Brief Summary

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

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Diagnostic performance

Time Frame: 12 months

Specificity and sensitivity of the device performance in regard to vaginitis conditions

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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