Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorBaxter Healthcare Corporation
About this trial
The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Volara therapy
DeviceOscillation and Lung Expansion (OLE) therapy, is a respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Single Group AssignmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in mucus plug volume (mL)
Assessed based on movement of mucus plugs and/or clearance from segmental airways
Time frame
28 DaysSponsors and contacts
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Source ClinicalTrials.gov
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