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Clinical Trials/NCT00672893
NCT00672893
Completed
Not Applicable

Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure

Deep Breeze5 sites in 4 countries200 target enrollmentFebruary 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Central Airway Stenosis
Sponsor
Deep Breeze
Enrollment
200
Locations
5
Primary Endpoint
The principal objective is to determine the ability of the VRI to assess changes in the lungs before and after pulmonary intervention in patients suffering from airway obstruction.
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

Vibration response imaging (VRI) technology, provides a radiation-free dynamic image of the lung, by visualizing vibration energy emitted during the respiration cycle (lung sounds). Airflow in the lungs during the respiration cycle creates vibrations that propagate through the lung tissue; these vibrations are affected by the structural properties of the lungs and may vary in space, time and frequency. Moreover, any structural alteration, such as a bronchial obstruction or space occupying infiltration, is reflected in a corresponding modification of the vibration response.

As obstructions that occur in airways alter airflow, the VRI may provide additional lung function information prior to treatment for airway obstruction and during follow-up. Moreover, the VRI may provide the physician immediate evaluation of the improvement of air flow distribution, quantitative and qualitative measurements. Furthermore, the VRI is a non-invasive, radiation free procedure which is simple and doesn't require the level of patient effort required for lung function test and other evaluation.

Registry
clinicaltrials.gov
Start Date
February 2006
End Date
December 2008
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Deep Breeze

Eligibility Criteria

Inclusion Criteria

  • Patient is able to read and understand the Informed Consent Form and he/she will sign the Informed Consent.
  • Male or female in the age range of 18-85 years.
  • Body Mass Index \>
  • Patient presented with airway obstruction and who are designated to undergo intervention

Exclusion Criteria

  • Chest wall deformity;
  • Spine deformity (including severe scoliosis or kyphosis);
  • Hirsutism;
  • Potentially contagious skin lesion on the back;
  • Skin lesion that would interfere with sensor placement;
  • Patient is pregnant;
  • Cardiac pacemaker or implantable defibrillator;

Outcomes

Primary Outcomes

The principal objective is to determine the ability of the VRI to assess changes in the lungs before and after pulmonary intervention in patients suffering from airway obstruction.

Time Frame: Baseline and follow-up up to 3 months

Secondary Outcomes

  • The secondary objective is to assess the contribution of the VRI in aiding in identification of the pulmonary obstruction as compared to the standard methods prior the intervention procedure.(Baseline)

Study Sites (5)

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