Trials / Unknown
UnknownNCT04816903
Gyni™ Study With Leumit Health Services
Gyni™ System Pilot Study With Leumit Health Services - Prospective Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- Sponsor
- GynTools Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
About one third of the women referring to gynecological clinics present with vulvovaginal inflammation symptoms (vaginitis) possibly caused by seven different conditions or mixed infections. The Gyni™ system is intended to provide physicians with the means to obtain an accurate, fast and inexpensive diagnosis which is unavailable today. Gyni™ is comprised of a compact tabletop scanner, a disposable sample collector and a cloud based algorithm that provides a suggested diagnosis within 5 minutes. The trial is a prospective evaluation of the cost-effectiveness of using Gyni™ by comparing its usage outcomes in a practice setting to the outcomes obtained using the current standard of care.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Gyni | Vaginal discharge collection |
Timeline
- Start date
- 2021-03-07
- Primary completion
- 2022-03-07
- Completion
- 2022-03-07
- First posted
- 2021-03-25
- Last updated
- 2021-03-25
Locations
4 sites across 1 country: Israel
Source: ClinicalTrials.gov record NCT04816903. Inclusion in this directory is not an endorsement.