CopdNCT04786171
4D Medical X-ray Velocimetry for Bronchoscopic Lung Volume Reduction Targeting
An observational study of Copd and Emphysema, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This study will investigate the utility of 4D Medical's X-ray Velocimetry (XV) imaging analysis software for the detection of hyperinflation, and compare endobronchial valve placement outcomes with predictive indices obtained utilizing this technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd, Emphysema, Hyperinflation
- What is being tested?
- 4D X-ray Velocimetry
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2021to 30 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with symptomatic emphysema with hyperinflation and no conflating lung diseases or pregnancy.
Who may be able to join
- CT chest and PFTs within the last two years
- Age over 18
- COPD with emphysema
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) 3 - 4 classification OR modified Medical Research Council (mMRC) score of 2 or greater.
Who cannot join
- Pregnancy
- Presence of an additional pulmonary disease beyond COPD
- Inability to raise arms above 90 degrees as required for fluoroscopy
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: 4DXV for Targeting in Bronchoscopic Lung Volume Reduction
This study will investigate the utility of 4D Medical's X-ray Velocimetry (XV) imaging analysis software for the detection of hyperinflation, and compare endobronchial valve placement outcomes with predictive indices obtained utilizing this technique.
- Conditions
- Copd, Emphysema, Hyperinflation
- Being tested
- 4D X-ray Velocimetry
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D X-ray VelocimetryDiagnostic test
X-ray velocimetry uses fluoroscopy to quantify local ventilation in the lung.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of residual volume over functional residual capacity by 4DXV
We will compare an XV hyperinflation index to traditional pulmonary function tests (PFTs) and outcomes
Measured: 6 months
Expiratory Time Constants vs Fissure Completeness
We will examine the correlation between lobar expiratory time constants and fissure completeness by StratX
Measured: 1 year
Secondary outcomes (1)
Improvement in Saint George Respiratory Questionnaire (SGRQ)
We will compare SGRQs pre and post valve placement to hyperinflative indices by 4D XV
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start7 Jan 2021
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Thoracic Society
- Responsible party
- Principal investigator, Michael Lester, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786171
- Sponsor's protocol ID
- 12345678910
- Status last verified
- Jun 2024
- First submitted
- 3 Mar 2021
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4DXV for Targeting in Bronchoscopic Lung Volume Reduction
- ClinicalTrials.gov ID
- NCT04786171
- Acronym / sponsor ID
- 12345678910
- Conditions
- Copd, Emphysema, Hyperinflation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- American Thoracic Society
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 8 Mar 2021 (actual)
- 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.
This study will investigate the utility of 4D Medical's X-ray Velocimetry (XV) imaging analysis software for the detection of hyperinflation, and compare endobronchial valve placement outcomes with predictive indices obtained utilizing this technique.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with symptomatic emphysema with hyperinflation and no conflating lung diseases or pregnancy.
Key inclusion criteria (4 listed)
- CT chest and PFTs within the last two years
- Age over 18
- COPD with emphysema
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) 3 - 4 classification OR modified Medical Research Council (mMRC) score of 2 or greater.
Key exclusion criteria (3 listed)
- Pregnancy
- Presence of an additional pulmonary disease beyond COPD
- Inability to raise arms above 90 degrees as required for fluoroscopy
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 |
|---|---|---|
| 4D X-ray VelocimetryX-ray velocimetry uses fluoroscopy to quantify local ventilation in the lung. | Diagnostic test | – |
Primary outcome
Ratio of residual volume over functional residual capacity by 4DXV
Time frame: 6 months
We will compare an XV hyperinflation index to traditional pulmonary function tests (PFTs) and outcomes
Expiratory Time Constants vs Fissure Completeness
Time frame: 1 year
We will examine the correlation between lobar expiratory time constants and fissure completeness by StratX
1 secondary outcome
Improvement in Saint George Respiratory Questionnaire (SGRQ)
Time frame: 1 year
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 21 Jun 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Copd and Emphysema, run by Vanderbilt University Medical Center at 1 site in United States.
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 3 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 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Ratio of residual volume over functional residual capacity by 4DXV (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2024.