Cardio-pulmonary Diseases Clinical Trial
Official title:
Detection and Characterization of Cardio-pulmonary Patho-physiological States and Diseases by Ultrasound Transthoracic Doppler
| Verified date | May 2011 |
| Source | Echosense Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | August 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Elisha hospital | Haifa |
| Lead Sponsor | Collaborator |
|---|---|
| Echosense Ltd. |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diagnose specific pattern of LDS signals as Power and Velocity in pulmonary diseases in comparison to controls. | 1 year | No |