No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
5 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
85 (estimated)
Sponsor
Delve Health · Other
Who this trial is looking for
This trial is looking for patients with bronchiectasis who have had breathing problems recently. Participants will use a new device called BiWaze Clear to help clear their airways over a period of six months.
Are You a Good Fit for This Trial?
You may be able to join if
I am older than 5 years old
I have been diagnosed with bronchiectasis
I have had one or more breathing problems in the last 6 months
I can do the BiWaze Clear therapy as instructed
I am stable in my breathing at the time of screening
I can provide signed consent
You may not be able to join if
I have a rapidly progressing neuromuscular disease
I need to be hospitalized in the next six months
I had a pneumothorax in the last 6 months
I have used OLE therapy in the last 12 months
I am currently enrolled in a different study
I smoke or have used tobacco in the last 30 days
I am pregnant or breastfeeding
I have significant medical conditions that affect my health
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 a…
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria
To be eligible to participate in this study, an individual must meet all of the following criteria:
1. Patients aged \> 5 years old.
2. History of one or more respiratory exacerbations in the past 6 months or two or more respiratory exacerbations in the past 12 months, which req…
Inclusion Criteria
To be eligible to participate in this study, an individual must meet all of the following criteria:
1. Patients aged \> 5 years old.
2. 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.
3. Ability to perform BiWaze Clear therapy as prescribed.
4. Clinically stable respiratory status at the time of screening.
5. Bronchiectasis diagnosis (including patients with cystic fibrosis with documented bronchiectasis).
6. Signed informed consent (and Child assent if minor subject).
Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participating in this study:
1. Diagnosis with rapidly progressing NMD.
2. Anticipated requirement for hospitalization within the next six months.
3. History of pneumothorax within the past 6 months.
4. Use of OLE therapy within the past 12 months.
5. Inability or unwillingness to perform OLE therapy or study procedures as required.
6. Currently enrolled in a different study.
7. Current smoker or tobacco use within the last 30 days.
8. Pregnancy or Breastfeeding.
9. Any medical conditions deemed by investigators to have a significant impact on the study results, e.g., active cancer, severe cardiovascular, severe progressive pulmonary disease, liver, kidney, or neurological conditions.
10. Inability to comply with the treatment protocol or study procedures.
11. Known allergies to materials used in OLE device.
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