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OLE Therapy With BE Patients in Home Care Study
Sponsor: Delve Health
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 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.
Official title: Oscillating Lung Expansion (OLE) Therapy in the Bronchiectasis Patients (BE) Home Care Study Protocol
Key Details
Gender
All
Age Range
5 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
85
Start Date
2025-05-20
Completion Date
2026-08-31
Last Updated
2025-09-29
Healthy Volunteers
No
Conditions
Interventions
BiWaze Clear System
The BiWaze Clear device includes several components as follows: 1. BiWaze Clear System. 2. BiWaze Clear Dual Lumen Breathing Circuit. * Dual Lumen bacterial/viral filter. * Dual Lumen breathing tube. * Patient Interface (Anesthesia mask \[small, medium or large\], Mouthpiece, or trach adapter). 3. Carrying Bag. The patient will perform airway clearance therapy with the BiWaze Clear System
Locations (4)
Central Florida Pulmonary Group, P.A.
Orlando, Florida, United States
Treasure Coast Medical Research Group, LLC
Port Saint Lucie, Florida, United States
Metropolitan Clinical Research
Tamarac, Florida, United States
University of South Florida -Tampa General Hospital
Tampa, Florida, United States