Actively Recruiting
OLE Therapy With BE Patients in Home Care Study
Led by Delve Health · Updated on 2026-04-14
85
Participants Needed
5
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
OLE Therapy With BE Patients in Home Care Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged > 5 years old
- History of one or more respiratory exacerbations in the past 6 months or two or more in the past 12 months requiring unplanned or unscheduled medical intervention
- Ability to perform BiWaze Clear therapy as prescribed
- Clinically stable respiratory status at screening
- Diagnosed with Bronchiectasis, including cystic fibrosis with documented bronchiectasis
- Signed informed consent and child assent if a minor subject
You will not qualify if you...
- Diagnosis with rapidly progressing neuromuscular disease (NMD)
- Expected hospitalization within the next 6 months
- History of pneumothorax within the past 6 months
- Use of Oscillating Lung Expansion therapy within the past 12 months
- Inability or unwillingness to perform OLE therapy or study procedures
- Currently enrolled in another study
- Current smoker or tobacco use within the last 30 days
- Pregnancy or breastfeeding
- Medical conditions impacting study results such as active cancer, severe cardiovascular, progressive pulmonary disease, liver, kidney, or neurological conditions
- Inability to comply with treatment protocol or study procedures
- Known allergies to materials used in the OLE device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
Central Florida Pulmonary Group, P.A.
Orlando, Florida, United States, 32803
Actively Recruiting
3
Treasure Coast Medical Research Group, LLC
Port Saint Lucie, Florida, United States, 34986
Actively Recruiting
4
Metropolitan Clinical Research
Tamarac, Florida, United States, 33321
Actively Recruiting
5
University of South Florida -Tampa General Hospital
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
T
Theresa Dahl, Master Clinical Pathology
CONTACT
W
Wessam Sonbol, CEO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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