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Air TrappingLungs and breathingDrugDeviceEarly Phase 1

What this study is

Simplified from ClinicalTrials.gov

Testing airway scaffolds placed through a bronchoscope (Apreo BREATHE System) to learn, using xenon MRI lung scans, whether they reduce areas of poor airflow and improve gas exchange in people with emphysema and air trapping, ages 40 to 84, who are already enrolled in the BREATHE-3 study.

Read the original summary from ClinicalTrials.gov

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.

What's being tested

  • Hyperpolarized Xenon MRI

    Intervention · DRUG

    Hyperpolarized Xenon MRI (HP ¹²#Xe) is a radiation-free imaging technique that boosts signal strength to create high-resolution images of how gas moves through the lungs. By tracking inhaled gas across separate breath-holds, it measures airflow blockage, tissue transfer efficiency, and gas uptake by red blood cells, while a washout test maps how well the lungs clear gas. It has been applied to characterize pulmonary impairment in COPD and emphysema and to detect regional ventilation changes following bronchoscopic interventions.

  • Apreo BREATHE Airway Scaffold

    Intervention · DEVICE

    The experimental treatment involves placement of up to 6 Apreo BREATHE Airway Scaffolds (up to 3 per lung), in a single procedure using bronchoscopy and fluoroscopy. Treatment group subjects will also receive optimal medical management (OMM). The BREATHE Airway Scaffold implant procedure occurs under the BREATHE-3 main study. This procedure is not part of the BREATHE-Xe study, which focuses on changes in regional ventilation.

Study details

Sponsor
Apreo Health, Inc.
Conditions
Air Trapping · Emphysema · Hyperinflation
Enrolling
15 people
Starts
2026-10
Est. completion
2028-11
Design
Open-label, single group, Early Phase 1
Record
View on ClinicalTrials.gov ↗