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

Completed

• Conditions: Copd; Emphysema; Hyperinflation

• Registration Number: NCT04786171
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-07
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-08
• Primary Completion: 2024-05-30
• Study Completion: 2024-05-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expiratory Time Constants vs Fissure Completeness	1 year	We will examine the correlation between lobar expiratory time constants and fissure completeness by StratX
Ratio of residual volume over functional residual capacity by 4DXV	6 months	We will compare an XV hyperinflation index to traditional pulmonary function tests (PFTs) and outcomes

Secondary Outcome Measures

Name	Time	Method
Improvement in Saint George Respiratory Questionnaire (SGRQ)	1 year	We will compare SGRQs pre and post valve placement to hyperinflative indices by 4D XV

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States