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

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.

Study Overview

• Status: Recruiting
• Conditions: Emphysema; Copd; Hyperinflation
• Intervention / Treatment: Diagnostic test: 4D X-ray Velocimetry

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Michael Lester; Phone Number: 2566830228; Email: michael.g.lester@vumc.org
• Study Contact Backup: Name: Robert Lentz; Phone Number: (832) 259-4396; Email: robert.j.lentz@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Michael G Lester, MD; Phone Number: 256-683-0228; Email: michael.g.lester@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults with symptomatic emphysema with hyperinflation and no conflating lung diseases or pregnancy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Expiratory Time Constants vs Fissure Completeness	We will examine the correlation between lobar expiratory time constants and fissure completeness by StratX	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: American Thoracic Society

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2021
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Emphysema
• Other Study ID Numbers: 12345678910

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No