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Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

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

NCT06937216•Baxter Healthcare Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Documented diagnosis of COPD with or without bronchiectasis.
•2. Age ≥ 21 years.
•3. Naive to Volara therapy.
•4. FEV1 \< 80% predicted (based on pulmonary function tests within the past 12 months).
•5. Daily sputum production over the prior 2 weeks.
•6. Signed informed consent.
•7. Stable pulmonary disease defined as no change in disease status.
•8. Stable medication regimen for 30 days prior to visit 1, defined as no change in prescribed medications and adherence to their prescribed medications for pulmonary disease

Exclusion Criteria

•1. Anticipated requirement for hospitalisation within the next 35 days (± 1 day).
•2. History of pneumothorax within the past 6 months prior to visit 1.
•3. History of haemoptysis requiring embolization within the past 12 months prior to visit 1.
•4. Inability or unwillingness to perform Volara System therapy as directed, without healthcare provider support.
•5. Inability or unwillingness to complete study visits and/or provide follow-up data as required per the study protocol.
•6. Inability to complete a 6-minute walk.
•7. Actively participating in another clinical trial involving an investigational medication or device.
•8. Pregnant females as verified by point of care human chorionic gonadotropin test.
•9. Current Intrapulmonary Percussive Ventilation and/or oscillation and lung expansion users.
•10. Participant requires a prescribed daily regimen for airway clearance with a device or with manual therapy in addition to Volara.
+2 more criteria

Locations (1)

Medimprove

Kontich, Belgium

Key Dates

Start Date

May 1, 2025

Primary Completion Date

September 1, 2025

Completion Date

November 1, 2025

Last Updated

April 22, 2025

Enrollment

ESTIMATED participants

Conditions

Bronchiectasis AdultCOPD

Interventions

Volara therapy

DEVICE

Contacts

Danielle Endres, RN

CONTACT

+13157296141 danielle_endres@baxter.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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