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Diagnosis of Pulmonary Embolism by Doppler Signals

Primary Purpose

Pulmonary Embolism

Status

Terminated

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Diagnostic ultrasound radiation

About this trial

This is an interventional diagnostic trial for Pulmonary Embolism focused on measuring pulmonary embolism, pulmonary disease, Lung Doppler signals

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rambam

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic ultrasound

Arm Description

Recording Doppler ultrasound signals noninvasively from the right chest wall

Outcomes

Primary Outcome Measures

Identify lack of Lung Doppler signals in specific lung sections that were diagnosed obstructed by CT

The obstructed sections will be compared with healthy lung sections

Secondary Outcome Measures

Full Information

NCT ID

NCT02652689

First Posted

January 5, 2016

Last Updated

February 7, 2019

Sponsor

Echosense Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02652689

Brief Title

Diagnosis of Pulmonary Embolism by Doppler Signals

Official Title

Transthoracic Parametric Doppler Assessment of Lung Doppler Signals in Acute Pulmonary Embolism

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Terminated

Study Start Date

April 2016 (undefined)

Primary Completion Date

December 2018 (Actual)

Study Completion Date

January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Echosense Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Embolism

Keywords

pulmonary embolism, pulmonary disease, Lung Doppler signals

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic ultrasound

Arm Type

Experimental

Arm Description

Recording Doppler ultrasound signals noninvasively from the right chest wall

Intervention Type

Radiation

Intervention Name(s)

Diagnostic ultrasound radiation

Intervention Description

Recording Doppler ultrasound signals from the right chest wall

Primary Outcome Measure Information:

Title

Identify lack of Lung Doppler signals in specific lung sections that were diagnosed obstructed by CT

Description

The obstructed sections will be compared with healthy lung sections

Time Frame

30min

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diana Gaitini, MD

Organizational Affiliation

Rambam Health Care Campus

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rambam

City

Haifa

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Diagnosis of Pulmonary Embolism by Doppler Signals

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