Oscillating Lung Expansion (OLE) Therapy in the Bronchiectasis Patients (BE) Home Care Study Protocol

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 85
Healthy Volunteers: f
View:

• 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).

Locations
United States
Florida
Central Florida Pulmonary Group, P.A.
RECRUITING
Orlando
Treasure Coast Medical Research Group, LLC
RECRUITING
Port Saint Lucie
Metropolitan Clinical Research
RECRUITING
Tamarac
University of South Florida -Tampa General Hospital
NOT_YET_RECRUITING
Tampa
Contact Information
Primary
Ola CRM, Master Clinical Pathology
osoliman@delvehealth.com
952-200-6228
Backup
Wessam Sonbol, CEO
wsonbol@delvehealth.com
16123969538
Time Frame
Start Date: 2025-05-20
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 85
Treatments
Experimental: BiWaze Study Device treatment single Arm
All patients will be assigned to a single treatment arm utilizing BiWaze Clear System
Related Therapeutic Areas
Sponsors
Leads: Delve Health

This content was sourced from clinicaltrials.gov