Skip to main content
OpenTrials
Completed

NCT Number: NCT04786171

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COPD Chronic Disease Disease Attributes Emphysema Hyperinflation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4D X-ray Velocimetry

Diagnostic Test

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Improvement in Saint George Respiratory Questionnaire (SGRQ)

    Time frame: 1 year

    We will compare SGRQs pre and post valve placement to hyperinflative indices by 4D XV

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • American Thoracic Society

Registry information

Official study title

4DXV for Targeting in Bronchoscopic Lung Volume Reduction

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2021
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.