4D Medical X-ray Velocimetry for Bronchoscopic Lung Volum... | NCT04786171

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

NCT04786171

Sponsor

Vanderbilt University Medical Center

Status

Completed

Last Update Posted

Jun 21, 2024Actual

Enrollment

17Actual

Phase

Not provided

Conditions

Copd
Emphysema
Hyperinflation

Interventions

4D X-ray Velocimetry

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2021Actual

Primary Completion Date

May 30, 2024Actual

Completion Date

May 30, 2024Actual

First Submitted Date

Mar 3, 2021

First Submission Date that Met QC Criteria

Mar 3, 2021

First Posted Date

Mar 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2024

Last Update Posted Date

Jun 21, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael Lester, Fellow/Assistant Professor of Pulmonary and Critical Care Medicine, Vanderbilt University Medical CenterPrincipal Investigator

Lead Sponsor

Vanderbilt University Medical CenterOTHER

Collaborators

Name	Class
American Thoracic Society	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
4D X-ray Velocimetry	Diagnostic Test	X-ray velocimetry uses fluoroscopy to quantify local ventilation in the lung.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center		Nashville	Tennessee	37232	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D004646	Emphysema

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided