Clinical Trial

OLE Therapy With BE Patients in Home Care Study

Recruiting
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Record status
This record was last updated April 14, 2026 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-04-08; most recent amendment 2026-04-09.
Status change: Not Yet Recruiting → Recruiting 2025-09-23
Trial Details
NCT Number NCT06926881
Lead Sponsor Delve Health
Conditions Bronchiectasis, Pulmonary Exacerbation
Enrollment 85 participants
Start Date 2025-05-20
Primary Completion 2026-05-31 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-14