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4D Medical X-ray Velocimetry for Bronchoscopic Lung Volume Reduction Targeting

4DXV for Targeting in Bronchoscopic Lung Volume Reduction

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04786171
Enrollment
17
Registered
2021-03-08
Start date
2021-01-07
Completion date
2024-05-30
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Copd, Emphysema, Hyperinflation

Brief 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.

Interventions

DIAGNOSTIC_TEST4D X-ray Velocimetry

X-ray velocimetry uses fluoroscopy to quantify local ventilation in the lung.

Sponsors

American Thoracic Society
CollaboratorOTHER
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion: * 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.

Exclusion criteria

* Pregnancy * Presence of an additional pulmonary disease beyond COPD * Inability to raise arms above 90 degrees as required for fluoroscopy

Design outcomes

Primary

MeasureTime frameDescription
Ratio of residual volume over functional residual capacity by 4DXV6 monthsWe will compare an XV hyperinflation index to traditional pulmonary function tests (PFTs) and outcomes
Expiratory Time Constants vs Fissure Completeness1 yearWe will examine the correlation between lobar expiratory time constants and fissure completeness by StratX

Secondary

MeasureTime frameDescription
Improvement in Saint George Respiratory Questionnaire (SGRQ)1 yearWe will compare SGRQs pre and post valve placement to hyperinflative indices by 4D XV

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026