NCT06926881 · Delve Health
OLE Therapy With BE Patients in Home Care Study
What this study is about
The study will examine how the performance of Oscillating Lung Expansion (OLE) therapy affects the respiratory health of patients with Bronchiectasis (BE). The patient will use the BiWaze Clear system for their airway clearance therapy, instead of their previously prescribed therapy.
View original scientific description
The study will examine how the performance of Oscillating Lung Expansion (OLE) therapy affects the respiratory health of patients with Bronchiectasis (BE). The patient will use the BiWaze Clear system for their airway clearance therapy, instead of their previously prescribed therapy. BiWaze Clear is an FDA-cleared respiratory therapy for assisting patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high-frequency oscillation therapies, combined with aerosol delivery. The patient will perform airway clearance with BiWaze Clear as prescribed. The system uses a disposable breathing circuit, which is a single patient use, disposable circuit. The treatment duration is 6 months . The BiWaze Clear System is indicated for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis and has the ability to provide supplemental oxygen when used with an oxygen supply.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Patients aged \> 5 years old.
- 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.
- Ability to perform BiWaze Clear therapy as prescribed.
- Clinically stable respiratory status at the time of screening.
- Bronchiectasis diagnosis (including patients with cystic fibrosis with documented bronchiectasis).
- 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:
- Diagnosis with rapidly progressing NMD.
- Anticipated requirement for hospitalization within the next six months.
- History of pneumothorax within the past 6 months.
- Use of OLE therapy within the past 12 months.
- Inability or unwillingness to perform OLE therapy or study procedures as required.
- Currently enrolled in a different study.
- Current smoker or tobacco use within the last 30 days.
- Pregnancy or Breastfeeding.
- 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.
- Inability to comply with the treatment protocol or study procedures.
- Known allergies to materials used in OLE device.
Where
- New Haven, Connecticut
- Orlando, Florida
- Port Saint Lucie, Florida
- Tamarac, Florida
- Tampa, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 14, 2026 · Source of record for eligibility and locations