NCT01225367

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 13, 2015

Status Verified

May 1, 2011

Enrollment Period

4.8 years

First QC Date

October 19, 2010

Last Update Submit

August 12, 2015

Conditions

Pulmonary PathologiesCardio-pulmonary Diseases

Outcome Measures

Primary Outcomes (1)

  • Diagnose specific pattern of LDS signals as Power and Velocity in pulmonary diseases in comparison to controls.

    1 year

Study Arms (1)

pulmonary doppler

Device: ultrasound doppler monitoring

Interventions

ultrasound doppler monitoringDEVICE

Regular noninvasive chest echo monitoring

pulmonary doppler

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

primary care clinic

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elisha hospital

Haifa, 31064, Israel

Location

Study Officials

  • Moshe Person, MD

    Elisha Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2010

First Posted

October 21, 2010

Study Start

August 1, 2010

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

August 13, 2015

Record last verified: 2011-05

Locations

IL(1)