Diagnosis of Pulmonary Embolism by Doppler Signals | NCT02652689

Studies
Diagnosis of Pulmonary Embolism by Doppler Signals

NCT02652689

Sponsor

Echosense Ltd.

Status

Terminated

Last Update Posted

Feb 8, 2019Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Pulmonary Embolism

Interventions

Diagnostic ultrasound radiation

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Dec 2018Actual

Completion Date

Jan 2019Actual

First Submitted Date

Jan 5, 2016

First Submission Date that Met QC Criteria

Jan 8, 2016

First Posted Date

Jan 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2019

Last Update Posted Date

Feb 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diagnostic ultrasound	Experimental	Recording Doppler ultrasound signals noninvasively from the right chest wall	Radiation: Diagnostic ultrasound radiation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diagnostic ultrasound radiation	Radiation	Recording Doppler ultrasound signals from the right chest wall	Diagnostic ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	30min

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Diana Gaitini, MD	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam		Haifa			Israel

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011655	Pulmonary Embolism
D008171	Lung Diseases

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided