New breathing device aims to cut lung infections in bronchiectasis patients
NCT ID NCT06926881
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a device called BiWaze Clear that helps people with bronchiectasis clear mucus from their lungs using gentle vibrations and lung expansion. About 85 participants will use the device at home for 6 months. Researchers will track how many lung infections they get compared to the year before starting the therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 85 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria To be eligible to participate in this study, an individual must meet all of the following criteria: 1. Patients aged \> 5 years old. 2. History of one or more respiratory exacerbations in the past 6 months or two or more respiratory exacerbations in the past 12 months, which required unplanned or unscheduled medical intervention. 3. Ability to perform BiWaze Clear therapy as prescribed. 4. Clinically stable respiratory status at the time of screening. 5. Bronchiectasis diagnosis (including patients with cystic fibrosis with documented bronchiectasis). 6. Signed informed consent (and Child assent if minor subject). Exclusion Criteria An individual who meets any of the following criteria will be excluded from participating in this study: 1. Diagnosis with rapidly progressing NMD. 2. Anticipated requirement for hospitalization within the next six months. 3. History of pneumothorax within the past 6 months. 4. Use of OLE therapy within the past 12 months. 5. Inability or unwillingness to perform OLE therapy or study procedures as required. 6. Currently enrolled in a different study. 7. Current smoker or tobacco use within the last 30 days. 8. Pregnancy or Breastfeeding. 9. Any medical conditions deemed by investigators to have a significant impact on the study results, e.g., active cancer, severe cardiovascular, severe progressive pulmonary disease, liver, kidney, or neurological conditions. 10. Inability to comply with the treatment protocol or study procedures. 11. Known allergies to materials used in OLE device.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Central Florida Pulmonary Group, P.A.
RECRUITINGOrlando, Florida, 32803, United States
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Metropolitan Clinical Research
RECRUITINGTamarac, Florida, 33321, United States
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Treasure Coast Medical Research Group, LLC
RECRUITINGPort Saint Lucie, Florida, 34986, United States
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University of South Florida -Tampa General Hospital
RECRUITINGTampa, Florida, 33612, United States
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Yale School of Medicine
RECRUITINGNew Haven, Connecticut, 06510, United States
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Other studies related to the condition(s) this trial covers.
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