Bronchiectasis AdultNCT06937216
Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production
A study testing Volara therapy in people with Bronchiectasis Adult and COPD, run by Baxter Healthcare Corporation at 1 site in Belgium.
Trial summary
The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Bronchiectasis Adult, COPD
- What is being tested?
- Volara therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- May 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Medimprove
Kontich
Wendel Dierckx, wendel.dierckx@fluidda.com
Wilfried De Backer
About this study
The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance.
Read the 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.
- Conditions
- Bronchiectasis Adult, COPD
- Being tested
- Volara therapy
- Keywords
- Volara, OLE Therapy, mucous clearance
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volara therapyDevice
Oscillation and Lung Expansion (OLE) therapy, is a respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Experimental | Each participant will be his/her own control comparing their baseline status to an active treatment period. Receives: Device: Volara therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mucus plug volume (mL)
Assessed based on movement of mucus plugs and/or clearance from segmental airways
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will be a single arm, monocentric, prospective, pilot study.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937216
- Sponsor's protocol ID
- BXU602317
- Other IDs
- CIV-25-04-052074
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production
- ClinicalTrials.gov ID
- NCT06937216
- Acronym / sponsor ID
- BXU602317
- Conditions
- Bronchiectasis Adult, COPD
- Keywords
- Volara, OLE Therapy, mucous clearance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will be a single arm, monocentric, prospective, pilot study.
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | Experimental | Device: Volara therapyEach participant will be his/her own control comparing their baseline status to an active treatment period. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volara therapyOscillation and Lung Expansion (OLE) therapy, is a respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure | Device | Single Group Assignment |
Primary outcome
Change in mucus plug volume (mL)
Time frame: 28 Days
Assessed based on movement of mucus plugs and/or clearance from segmental airways
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volara therapy in people with Bronchiectasis Adult and COPD, run by Baxter Healthcare Corporation at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle Endres, RN (+13157296141, danielle_endres@baxter.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mucus plug volume (mL) (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.