BiWaze ClearOLE Therapy With BE Patients in Home Care Study

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.