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OpenTrials
Completed

NCT Number: NCT00473291

Vibration Response Imaging (VRI) in Management and Evaluation in Patients With Pleural Effusion

The primary purpose of this study is evaluate the VRI device's accuracy in diagnosis of pleural effusion (in comparison to chest x-ray and ultrasonography), and to assess the pleural effusion location and size. The VRI system uses pressure sensors (electronic stethoscopes) to record the energy created by the airflow in the lungs during breathing.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center, Harvard Medical School

Boston, Massachusetts, 02215, United States

About this study

The accumulation of excess fluid in the pleural cavity of the lungs, known as pleural effusion, is a common clinical condition that may be the result of trauma or disease. Diagnosis and management of pleural effusion can be done by X-Ray or ultrasound; however X-Ray emits radiation, requires a special room and expert personnel, while ultrasound requires a high level of expertise to perform and analyze. The VRI device is non-invasive and radiation free. The VRI device is a simple method to image the lungs in a regional manner to examine changes that occur during pleural effusion.

Comparison: X-ray and ultrasonography evaluations of pleural effusion, compared to VRI acoustic imaging evaluations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able and willing to read, understand, and provide written Informed Consent;
  • Male or Female in the age range of 18-85 years;
  • Subject is suspected to have pleural effusion;
  • Body mass index (BMI) > 21.

Exclusion criteria

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

Sponsors and collaborators

Lead sponsor

Deep Breeze

Industry

Registry information

Important dates

Study start
2006
Study completion
2007
First posted
May 15, 2007
Registry last updated
Jun 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.