Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Volara therapy.
- Who it may be relevant to
- Registry conditions: Bronchiectasis Adult, COPD. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Change in mucus plug volume (mL) [Time frame: 28 Days]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Medimprove — Kontich
Identifiers
NCT: NCT06937216 · BXU602317 · CIV-25-04-052074