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OLE Therapy With BE Patients in Home Care Study

RecruitingNAAges 5 Years - anyAllDelve Health
NCT06926881 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • BiWaze Clear System
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Where

5 sites
Yale School of Medicine
New Haven, United States
Central Florida Pulmonary Group, P.A.
Orlando, United States
Treasure Coast Medical Research Group, LLC
Port Saint Lucie, United States
Metropolitan Clinical Research
Tamarac, United States
University of South Florida -Tampa General Hospital
Tampa, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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