Status:
NOT_YET_RECRUITING
Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
Bronchiectasis Adult
COPD
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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 quantitat...
Eligibility Criteria
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
- Anticipated requirement for hospitalisation within the next 35 days (± 1 day).
- 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.
- 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.
- Actively participating in another clinical trial involving an investigational medication or device.
- 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 a prescribed daily regimen for airway clearance with a device or with manual therapy in addition to Volara.
- Participant requires mechanical ventilation.
- Participants with artificial airways
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06937216
Start Date
May 1 2025
End Date
November 1 2025
Last Update
April 22 2025
Active Locations (1)
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1
Medimprove
Kontich, Belgium