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New breathing device aims to cut lung infections in bronchiectasis patients

NCT ID NCT06926881

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 85 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

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

5 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Central Florida Pulmonary Group, P.A.

    RECRUITING

    Orlando, Florida, 32803, United States

  • Metropolitan Clinical Research

    RECRUITING

    Tamarac, Florida, 33321, United States

  • Treasure Coast Medical Research Group, LLC

    RECRUITING

    Port Saint Lucie, Florida, 34986, United States

  • University of South Florida -Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33612, United States

  • Yale School of Medicine

    RECRUITING

    New Haven, Connecticut, 06510, United States

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