Trials / Completed
CompletedNCT04219605
Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 226 (actual)
- Sponsor
- Meir Medical Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
- Bacterial Vaginosis
- Candida Albicans Vulvovaginitis
- Candida Vulvovaginitis
- Trichomonas Vaginitis
- Atrophic Vaginitis
- Desquamative Inflammatory Vaginitis
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2022-10-30
- Completion
- 2023-03-30
- First posted
- 2020-01-07
- Last updated
- 2025-05-13
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT04219605. Inclusion in this directory is not an endorsement.