Diagnosis of Pulmonary Embolism by Doppler Signals

NCT ID: NCT02652689

Last Updated: 2019-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-01-31

Brief Summary

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The LDS may contain information of significant diagnostic and physiological value regarding the pulmonary parenchyma and vasculature, as well as the cardio- vascular system in general. In pilot clinical studies of patients with acute decompensated heart failure (ADHF) as well as patients with Pulmonary Hypertension, LDS signals patterns unique to these conditions were identified. We believe that these newly discovered ultrasound signals might provide a non-invasive radiation-free means to diagnose and monitor patients with Pulmonary Embolism.

The purpose of this study is to assess the utility of noninvasive assessment of lung Doppler signals performed via transthoracic parametric Doppler. The objective of the study is to evaluate the lung Doppler signals (LDS) in patients diagnosed with acute PE, in order to determine the potential assessment value of this non-invasive method in this potentially life threatening condition.

Detailed Description

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Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic ultrasound

Recording Doppler ultrasound signals noninvasively from the right chest wall

Group Type EXPERIMENTAL

Diagnostic ultrasound radiation

Intervention Type RADIATION

Recording Doppler ultrasound signals from the right chest wall

Interventions

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Diagnostic ultrasound radiation

Recording Doppler ultrasound signals from the right chest wall

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of acute PE on CTA

Exclusion Criteria

* Pregnant women
* Inability to consent
* Patients with severe chest wall deformity
* Previously diagnosed PE
* Pneumonia
* Pulmonary edema
* Pneumothorax
* Severe COPD (gold class III, IV)
* Hemodynamically unstable patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Echosense Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diana Gaitini, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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DOP023

Identifier Type: -

Identifier Source: org_study_id

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