Search > Native Lung Overinflation Syndrome
15 Participants NeededMy employer runs this trial

Apreo BREATHE System for Emphysema

(BREATHE-Xe Trial)

Recruiting at 1 trial location
NM
CH
Overseen ByCindy Holtz
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Apreo Health, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of this study is to provide a regional, mechanistic characterization of pulmonary ventilation changes following treatment with the Apreo BREATHE System, using hyperpolarized ¹²⁹Xe MRI, in BREATHE-3 participants. BREATHE-Xe is designed to generate mechanistic signals regarding whether airway scaffolds reduce ventilation defects, improve gas exchange, and correlate with CT and spirometric/plethysmographic changes observed in BREATHE-3. Findings support mechanistic interpretation and future hypothesis generation.

Who Is on the Research Team?

PN

Peter Niedbalski, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for people with emphysema who have trapped air or overinflated lungs. Participants should be eligible for bronchoscopic treatment and able to undergo MRI scans.

Inclusion Criteria

I can hold my breath for at least 10 seconds when instructed.
Willing and able to travel to KUMC or UAB for all scheduled Xe-MRI sessions
I am part of the BREATHE-3 study and in the Treatment arm or crossed over after 12 months.
See 2 more

Exclusion Criteria

Any absolute contraindication to MRI, including ferromagnetic implants not approved for MRI, cardiac pacemaker or ICD not MRI-conditional, cochlear implants, severe claustrophobia, or any condition judged incompatible with safe MRI by the investigator
Known allergy or hypersensitivity to xenon gas or components of the HP ¹²⁹Xe formulation
SpO₂ <88% at rest on the day of planned Xe-MRI, measured on the participant's usual oxygen (room air or standard supplemental oxygen per BREATHE-3 protocol or site standard of care), with supplemental oxygen removed only for preparation breaths and xenon inhalation then resumed
See 1 more

What Are the Treatments Tested in This Trial?

Interventions

  • Apreo BREATHE Airway Scaffold

Trial Overview

The study tests whether placing the Apreo BREATHE airway scaffold in the lungs improves breathing by reducing trapped air, using a special type of MRI scan (hyperpolarized xenon) to measure changes before and after treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: XENOVIEWExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Apreo Health, Inc.

Lead Sponsor

Trials
3
Recruited
330+

University of Alabama at Birmingham

Collaborator

Trials
1,677
Recruited
2,458,000+

University of Kansas Medical Center

Collaborator

Trials
527
Recruited
181,000+

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.