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Not yet recruitingNCT06937216Updated Apr 22, 2025

Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production

An interventional study of Volara therapy in Bronchiectasis Adult and COPD, sponsored by Baxter Healthcare Corporation. Not yet recruiting at 1 site in Belgium. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-04-22.

Sponsored by Baxter Healthcare Corporation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Bronchiectasis Adult
  • COPD

Keywords

  • Volara
  • OLE Therapy
  • mucous clearance
03

In context

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

This study's planned enrollment of 10 is below the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Baxter Healthcare Corporation is the lead sponsor of 80 studies on the registry; 1 is open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Browse Baxter Healthcare Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Documented diagnosis of with or without bronchiectasis.
  2. Age ≥ 21 years.
  3. Naive to Volara therapy.
  4. \< 80% predicted (based on pulmonary function tests within the past 12 months).
  5. Daily sputum production over the prior 2 weeks.
  6. Signed .
  7. Stable pulmonary disease defined as no change in disease status.
  8. 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

Exclusion Criteria:

  1. Anticipated requirement for hospitalisation within the next 35 days (± 1 day).
  2. History of pneumothorax within the past 6 months prior to visit 1.
  3. History of haemoptysis requiring embolization within the past 12 months prior to visit 1.
  4. Inability or unwillingness to perform Volara System therapy as directed, without healthcare provider support.
  5. Inability or unwillingness to complete study visits and/or provide follow-up data as required per the study protocol.
  6. Inability to complete a 6-minute walk.
  7. Actively participating in another clinical trial involving an medication or device.
  8. Pregnant females as verified by point of care human chorionic gonadotropin test.
  9. Current Intrapulmonary Percussive Ventilation and/or oscillation and lung expansion users.
  10. Participant requires a prescribed daily regimen for airway clearance with a device or with manual therapy in addition to Volara.
  11. Participant requires mechanical ventilation.
  12. Participants with artificial airways
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Single Group Assignment

    Each participant will be his/her own control comparing their baseline status to an active treatment period.

    Device: Volara therapy

Interventions

  • DeviceVolara therapy

    Oscillation and Lung Expansion (OLE) therapy, is a respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure

06

What researchers measure

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 Days

07

Study locations

1 site
  • Medimprove
    Kontich, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2025; primary completion for Sep 2025, 4 months later.

Of 87 industry-sponsored interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's planned 4 months is below that.

Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 15, 2025
First posted
Apr 22, 2025
StartEst.
May 2025
Primary completionEst.
Sep 2025
CompletionEst.
Nov 2025
Last update
Apr 22, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06937216
Lead sponsor
Baxter Healthcare Corporation
Responsible party
Sponsor
First posted
Apr 22, 2025
Start date
May 2025 (estimated)
Primary completion
Sep 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Apr 22, 2025

Study contacts

Danielle Endres, RN
Contact
danielle_endres@baxter.com
+13157296141

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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