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NCT03897140

Point-of-Care Echocardiography With Assistance Technology

Completed NA Last updated 17 September 2019
What this trial tests

NA trial testing Diagnostic Test: Limited Echocardiogram in Cardiac Disease in 240 participants. Completed in 23 May 2019.

Timeline
25 March 2019
Primary endpoint
23 May 2019
23 May 2019

Quick facts

Lead sponsorSara Guttas
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment240
Start date25 March 2019
Primary completion23 May 2019
Estimated completion23 May 2019
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Sara Guttas

Who can join

18 and older, any sex, with Cardiac Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Establish the effectiveness of the Bay Labs, Inc. EchoGPS software in enabling RNs to acquire echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA 510(k)-cleared, commercially available ultrasound device will be performed. Participants will have two scans, one by a registered nurse (RN) using the Terason uSmart 3200t with EchoGPS (Study Exam) and one by a sonographer using the Reference Device without EchoGPS guidance (Control Exam), under the same protocol. Study is non-significant risk (NSR).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Utility of a Deep-Learning Algorithm to Guide Novices to Acquire Echocardiograms for Limited Diagnostic Use.
    Narang A, Bae R, Hong H, Thomas Y, et al · · 2021 · cited 256× · PMID 33599681 · DOI 10.1001/jamacardio.2021.0185

Verify or expand the search:

Other recruiting trials for Cardiac Disease

Currently open trials in the same condition.

Other Sara Guttas trials

Trials by the same sponsor.

Verify against primary sources

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/NCT03897140.

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