Evaluation of the Diagnostic Value of the TPD System in Determining ADHF Causing Acute Dyspnea

NCT03998410 | Terminated DMC FDA Device

• 1 other identifier: DOP-27
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this study is to evaluate Lung Doppler signals (LDS) among patients presenting to the emergency department with acute dyspnea, in order to determine the diagnostic value of this non-invasive method to discriminate ADHF causing dyspnea from any other cause i.e., non-ADHF causes of dyspnea.

Conditions

ADHF

Keywords

ADHF Dyspnea ED

Outcome Measures

Primary Outcomes (1)

• Accuracy of diagnosis

  overall accuracy of the TPD system for the determination of ADHF causing acute dyspnea in an ED setting versus the gold standard (GS) diagnosis as determined by the final adjudicated diagnosis

  Average of 1 year

Secondary Outcomes (1)

• Sensitivity, Specificity, PPV, NPV of TPD diagnosis

  Average of 1 year

Interventions

Lung Doppler Signals DEVICE

Recording Doppler ultrasound on the right chest wall

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patients with acute onset dyspnea (defined as shortness of breath (SOB) at rest or on exertion) and diagnostic uncertainty of etiology where heart failure is in consideration.
• Patients designated to undergo chest X-ray as part of standard of care assessment.

You may not qualify if:

• Obvious trauma contributing to dyspnea
• Inability to provide written informed consent
• Not speaking English or Spanish
• Right-sided lobectomy
• Patients with implanted ventricular assist device
• Patient is unable to undergo the TPD test
• Patient is already enrolled in a clinical study with experimental medications

Sponsors & Collaborators

• Echosense Ltd.: lead

Study Sites (3)

Wayne State University

Detroit, Michigan, 48201, United States

Location

The university of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Study Officials

• Judd Hollander, MD

  judd.hollander@jefferson.edu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Recording Doppler US signals over the right wall chest

Study Record Dates

• First Submitted: June 23, 2019
• First Posted: June 26, 2019
• Study Start: September 15, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 19, 2024

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)