OLE Therapy With BE Patients in Home Care Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5+
SponsorDelve Health
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients aged > 5 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.
Clinically stable respiratory status at the time of screening.
Disqualifiers
Diagnosis with rapidly progressing NMD.
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.
Trial design
Design model
Single group
Treatments tested in this trial
BiWaze Clear System
DeviceThe 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
Treatment groups
85 Participants
are divided into 1 treatment groupGroup A: BiWaze Study Device treatment single ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the effectiveness of BiWaze Clear therapy in reducing the frequency of pulmonary exacerbations and improving clinical outcomes.
Quantify the frequency of pulmonary exacerbations over a 6-month period during BiWaze Clear therapy and compare this data to the number of exacerbations recorded in the 12 months prior to the initiation of therapy.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov