Tests the Volara System device for mucus clearance in adults with lung disease
Tests the Volara System device to clear mucus in adults with bronchiectasis or COPD.
Plain-language title generated from the registry record
Registry title: Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production
Key facts
- Where
- Kontich, BelgiumSee the site
Where in Belgium
- MedimproveKontich, BelgiumNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Baxter Healthcare Corporation
- Trial code
- NCT06937216
- Record updated
- 22 April 2025
- Original description
The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance.Read full original descriptionShow less
Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production
The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance.
Inclusion: Documented diagnosis of COPD with or without bronchiectasis; Age ≥ 21 years; Naive to Volara therapy; FEV1 < 80% predicted (based on pulmonary function tests within the past 12 months); Daily sputum production over the prior 2 weeks; Signed informed consent; Stable pulmonary disease defined as no change in disease status; 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: History of pneumothorax within the past 6 months prior to visit 1; History of haemoptysis requiring embolization within the past 12 months prior to visit 1; Inability or unwillingness to perform Volara System therapy as directed, without healthcare provider support; Actively participating in another clinical trial involving an investigational medication or device; Participant requires a prescribed daily regimen for airway clearance with a device or with manual therapy in addition to Volara; Anticipated requirement for hospitalisation within the next 35 days (± 1 day); Inability or unwillingness to complete study visits and/or provide follow-up data as required per the study protocol; Inability to complete a 6-minute walk; Pregnant females as verified by point of care human chorionic gonadotropin test; Current Intrapulmonary Percussive Ventilation and/or oscillation and lung expansion users; Participant requires mechanical ventilation; Participants with artificial airways.