NCT06937216

Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance.

Detailed description

The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance. Mucus volume (mL) measured by Functional Respiratory Imaging (FRI). FRI is a quantitative endpoint that identifies mucus plugs in the segmented airways. Mucus volume will be assessed based on movement of mucus plugs and/or clearance from segmental airways. CT scans are obtained to determine FRI and will be obtained and assessed at baseline and after the 4-week treatment period to assess changes in mucus volume within the airways, associated with the Volara treatment. The study will also provide insight into the mechanism of action of the therapy.

Conditions

• Bronchiectasis Adult
• COPD

Interventions

Type	Name	Description
DEVICE	Volara therapy	Oscillation and Lung Expansion (OLE) therapy, is a respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-09-01
• Completion: 2025-11-01
• First posted: 2025-04-22
• Last updated: 2025-04-22

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated device study