Central Airway StenosisNCT00672893
Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure
An observational study of Central Airway Stenosis, run by Deep Breeze at 5 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Central Airway Stenosis
- What is being tested?
- Vibration Response Imaging
- How many people
- 200 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Feb 2006to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
National Jewish Medical and Research Center
Denver, Colorado, 80602
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
- Conditions
- Central Airway Stenosis
- Being tested
- Vibration Response Imaging
- Keywords
- central airway stenosis, lung sounds, airway obstruction, bronchial obstruction, bronchoscopic treatment
- Medical subject headings
- Respiratory Sounds, Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration Response ImagingOther
12 seconds of recording lung sounds
| Study group | Role | What they receive |
|---|---|---|
| Observation | Patients who present to the clinic with airway obstruction and who are designated to undergo intervention Receives: Other: Vibration Response Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and follow-up up to 3 months
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startFeb 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Central Airway StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deep Breeze
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Heinrich D Becker, M.D., Principal investigator, Thoraxklinik at Heidelberg University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672893
- Sponsor's protocol ID
- DB035-Multi-site
- Other IDs
- DB020-Single-site
- Status last verified
- Jun 2009
- First submitted
- 1 May 2008
- Last updated
- 16 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. doi: 10.1159/000103558. Epub 2007 Jun 4.
PubMed 17551264Ernst A, Feller-Kopman D, Becker HD, Mehta AC. Central airway obstruction. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1278-97. doi: 10.1164/rccm.200210-1181SO.
PubMed 15187010
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure
- ClinicalTrials.gov ID
- NCT00672893
- Acronym / sponsor ID
- DB035-Multi-site
- Conditions
- Central Airway Stenosis
- Keywords
- central airway stenosis, lung sounds, airway obstruction, bronchial obstruction, bronchoscopic treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Deep BreezeIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Other: Vibration Response ImagingPatients who present to the clinic with airway obstruction and who are designated to undergo intervention |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibration Response Imaging12 seconds of recording lung sounds | Other | Observation |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2009.
- Background: PubMed 17551264Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. doi: 10.1159/000103558. Epub 2007 Jun 4.
- Background: PubMed 15187010Ernst A, Feller-Kopman D, Becker HD, Mehta AC. Central airway obstruction. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1278-97. doi: 10.1164/rccm.200210-1181SO.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heinrich D Becker, M.D. principal investigator
Thoraxklinik at Heidelberg University School of Medicine
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Airway Stenosis, run by Deep Breeze at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, France, Germany, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00672893, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2009.