Vibration Response Imaging (VRI) in Patients That Are Candidates for Undergoing Pulmonary Operation Procedure

This study has suspended participant recruitment.
(Enrollment was too slow and principal investigator moved to another country)
Sponsor:
Information provided by:
Deep Breeze
ClinicalTrials.gov Identifier:
NCT00523094
First received: August 29, 2007
Last updated: June 15, 2009
Last verified: June 2009
  Purpose

The primary objective of this study is to estimate the accuracy of the pre-operative VRI quantitative results versus the gold standard pre-operative perfusion scan.

The secondary objective is to assess the correlation of the predicted post-operative lung function with the observed post-operative lung function (forced expiratory volume in 1 second [FEV1] and diffusing capacity of the lung for carbon monoxide [DLCO]) in patients who underwent surgical resection.


Condition
Emphysema
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vibration Response Imaging (VRI) in Patients That Are Candidates for Undergoing Pulmonary Operation Procedure

Further study details as provided by Deep Breeze:

Estimated Enrollment: 75
Study Start Date: September 2007
Estimated Study Completion Date: July 2008
Detailed Description:

Pre lung operation candidates for procedures such as lung volume reduction surgery (LVRS), lung resection, bullectomy and lung transplant are frequently evaluated for differential lung function by a semi quantitative lung scintigraphy. VRI may offer the same differential lung function information for the physician without the risks, time and patient discomfort of lung scintigraphy in the treating physician office.

Moreover, VRI may provide a safe, quick and simple method to measure "split function" in lung cancer patients who are candidates for lung surgery. Thus eliminating the safety and complexity issue related with the current ventilation perfusion "split function" methods.

In addition the VRI may aid in achieving the goal of developing strategies to reduce risk and maximize the number of patients that can benefit from surgical therapy.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients evaluated for lung surgery who will undergo perfusion scan

Criteria

Inclusion Criteria:

  1. Able and willing to read, understand, and provide written informed consent;
  2. Male or female in the age range of 18-80 years;
  3. Patients who were referred to perform perfusion scan for pre lung surgery evaluation such as LVRS, thoracotomy, bullectomy and lobectomy.
  4. Body mass index (BMI) > 21.

Exclusion Criteria:

  1. Chest wall deformation;
  2. Spine deformation (including scoliosis);
  3. Hirsutism;
  4. Potentially contagious skin lesion on the back;
  5. Skin lesion that would interfere with sensor placement; (Keloids)
  6. Cardiac pacemaker or implantable defibrillator;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523094

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Deep Breeze
Investigators
Principal Investigator: Atul C. Mehta, M.D The Cleveland Clinic
  More Information

Publications:

Responsible Party: Merav Gat/VP Clinical Affairs, Deep Breeze
ClinicalTrials.gov Identifier: NCT00523094     History of Changes
Other Study ID Numbers: DB032
Study First Received: August 29, 2007
Last Updated: June 15, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 29, 2014