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

This study is currently recruiting participants.
Verified May 2011 by Echosense Ltd.
Sponsor:
Information provided by (Responsible Party):
Echosense Ltd.
ClinicalTrials.gov Identifier:
NCT01225367
First received: October 19, 2010
Last updated: August 18, 2013
Last verified: May 2011
  Purpose

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.


Condition Intervention
Pulmonary Pathologies
Cardio-pulmonary Diseases
Device: ultrasound doppler monitoring

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Detection and Characterization of Cardio-pulmonary Patho-physiological States and Diseases by Ultrasound Transthoracic Doppler

Further study details as provided by Echosense Ltd.:

Primary Outcome Measures:
  • Diagnose specific pattern of LDS signals as Power and Velocity in pulmonary diseases in comparison to controls. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
pulmonary doppler Device: ultrasound doppler monitoring
Regular noninvasive chest echo monitoring

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

primary care clinic

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225367

Contacts
Contact: Daniel Weiler-Ravell, MD +972-54 5322422 dani@echosense.co.il
Contact: Rachel Schatzberger, PhD +972- 4 -8500101 rachel@echosense.co.il

Locations
Israel
Elisha hospital Recruiting
Haifa, Israel, 31064
Contact: Daniel Weiler, MD    +972-54-5322422    dani@echosense.co.il   
Contact: Rachel Schatzberger, PhD    +972-4-8500101    rachel@echosense.co.il   
Sub-Investigator: Daniel Weiler, Dr         
Sponsors and Collaborators
Echosense Ltd.
Investigators
Principal Investigator: Moshe Person, MD Elisha Hospital
  More Information

No publications provided

Responsible Party: Echosense Ltd.
ClinicalTrials.gov Identifier: NCT01225367     History of Changes
Other Study ID Numbers: ES_DOP05
Study First Received: October 19, 2010
Last Updated: August 18, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Heart Disease
Respiratory Tract Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014