Status:
RECRUITING
OLE Therapy With BE Patients in Home Care Study
Lead Sponsor:
Delve Health
Conditions:
Bronchiectasis
Pulmonary Exacerbation
Eligibility:
All Genders
5-85 years
Phase:
NA
Brief Summary
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 syste...
Detailed Description
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 oxyge...
Eligibility Criteria
Inclusion
- Patients aged 5 to 85 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.
- Bronchiectasis diagnosis (including patients with cystic fibrosis with documented bronchiectasis).
- Signed informed consent (and Child assent if minor subject).
Exclusion
- Diagnosis with rapidly progressing NMD.
- Post bronchodilator FEV₁ ≥ 65 % predicted
- 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.
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT06926881
Start Date
May 20 2025
End Date
August 31 2026
Last Update
September 29 2025
Active Locations (4)
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1
Central Florida Pulmonary Group, P.A.
Orlando, Florida, United States, 32803
2
Treasure Coast Medical Research Group, LLC
Port Saint Lucie, Florida, United States, 34986
3
Metropolitan Clinical Research
Tamarac, Florida, United States, 33321
4
University of South Florida -Tampa General Hospital
Tampa, Florida, United States, 33612