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NCT04786171 Clinical Trial

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

Copd Clinical Trial

Official title:
4DXV for Targeting in Bronchoscopic Lung Volume Reduction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04786171
Other study ID # 12345678910
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 7, 2021
Est. completion date May 30, 2024

Study information
Verified date June 2024
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date May 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 4D X-ray Velocimetry
X-ray velocimetry uses fluoroscopy to quantify local ventilation in the lung.

Locations
Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)
Lead Sponsor Collaborator
Vanderbilt University Medical Center American Thoracic Society

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 6 months
Primary Expiratory Time Constants vs Fissure Completeness We will examine the correlation between lobar expiratory time constants and fissure completeness by StratX 1 year
Secondary Improvement in Saint George Respiratory Questionnaire (SGRQ) We will compare SGRQs pre and post valve placement to hyperinflative indices by 4D XV 1 year
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