Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Deep Breeze
ClinicalTrials.gov Identifier:
NCT00672893
First received: May 1, 2008
Last updated: June 15, 2009
Last verified: June 2009

May 1, 2008
June 15, 2009
February 2006
December 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00672893 on ClinicalTrials.gov Archive Site
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. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure
Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients in the age range of 18-85 and consisting of both male and females, who present to the clinic with airway obstruction and who are designated to undergo intervention.

Central Airway Stenosis
Other: Vibration Response Imaging
12 seconds of recording lung sounds
Observation
Patients who present to the clinic with airway obstruction and who are designated to undergo intervention
Intervention: Other: Vibration Response Imaging

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2008
December 2008   (final data collection date for primary outcome measure)

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;
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Japan
 
NCT00672893
DB035-Multi-site, DB020-Single-site
No
Prof. Heinrich D. Becker, MD, Thoraxklinik at Heidelberg University
Deep Breeze
Not Provided
Principal Investigator: Heinrich D Becker, M.D. Thoraxklinik at Heidelberg University School of Medicine
Deep Breeze
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP