The Use of a Ultra-sound of the Lung to Diagnose Lung Dis... | NCT01225367

Studies
The Use of a Ultra-sound of the Lung to Diagnose Lung Diseases

NCT01225367

Sponsor

Echosense Ltd.

Status

Completed

Last Update Posted

Aug 13, 2015Estimated

Enrollment

120Actual

Phase

Not provided

Conditions

Pulmonary Pathologies
Cardio-pulmonary Diseases

Interventions

ultrasound doppler monitoring

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

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

May 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Oct 19, 2010

First Submission Date that Met QC Criteria

Oct 19, 2010

First Posted Date

Oct 21, 2010Estimated

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

Aug 12, 2015

Last Update Posted Date

Aug 13, 2015Estimated

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 study is a prospective open evaluating study of Ultrasound/Doppler application to the chest cavity intended to detect and characterize pathologies of the pulmonary and cardio-vascular system.

The system is a noninvasive non-imaging device designated to monitor flow and movement velocity and display the data continuously.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pulmonary doppler			Device: ultrasound doppler monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound doppler monitoring	Device	Regular noninvasive chest echo monitoring	pulmonary doppler

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnose specific pattern of LDS signals as Power and Velocity in pulmonary diseases in comparison to controls.		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18y or older
patients who are clinically suspected of having a significant pulmonary or cardio-pulmonary disease
Patients with CHF
Patients with pulmonary hypertension
Patients with COPD
Patients with Asthma
Signed informed consent
Normal subjects

Exclusion Criteria:

Patients with unstable conditions: unstable angina, uncontrolled CHF, etc
Inability to assume a sitting or supine position
Patients with severe chest wall deformity

Accepts Healthy Volunteers

Yes

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

primary care clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Moshe Person, MD	Elisha Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Elisha hospital		Haifa		31064	Israel