NCT04786171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

3.4 years

First QC Date

March 3, 2021

Last Update Submit

June 18, 2024

Conditions

CopdEmphysemaHyperinflation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Improvement in Saint George Respiratory Questionnaire (SGRQ)

    1 year

Interventions

4D X-ray VelocimetryDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysema

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow/Assistant Professor of Pulmonary and Critical Care Medicine

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 8, 2021

Study Start

January 7, 2021

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

June 21, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)