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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00672893
Enrollment
200
Registered
2008-05-06
Start date
2006-02-28
Completion date
2008-12-31
Last updated
2009-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Airway Stenosis

Keywords

central airway stenosis, lung sounds, airway obstruction, bronchial obstruction, bronchoscopic treatment

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.

Interventions

12 seconds of recording lung sounds

Sponsors

Deep Breeze
Lead SponsorINDUSTRY

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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 \>20. * 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;

Design outcomes

Primary

MeasureTime frame
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.Baseline and follow-up up to 3 months

Secondary

MeasureTime frame
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

Countries

France, Germany, Japan, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026