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NCT04816903

Gyni™ Study With Leumit Health Services

Status unknown NA Last updated 25 March 2021
What this trial tests

NA trial testing Gyni in Vaginitis in 600 participants. Status unknown.

Timeline
7 March 2021
Primary endpoint
7 March 2022
7 March 2022

Quick facts

Lead sponsorGynTools Ltd.
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposediagnostic
Enrollment600
Start date7 March 2021
Primary completion7 March 2022
Estimated completion7 March 2022
Sites4 locations across Israel

Drugs / interventions tested

Conditions studied

Sponsor

GynTools Ltd.

Who can join

Adults 18 to 99, female only, with Vaginitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Vaginitis

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04816903.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing