Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Meir Medical Center
- 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