BridgeMD
New treatment option for Bronchiectasis
Official title OLE Therapy With BE Patients in Home Care Study
ClinicalTrials.gov ID: NCT06926881
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 and older
You may be able to join if
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- 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...
- Ability to perform BiWaze Clear therapy as prescribed.
- Clinically stable respiratory status at the time of screening.
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participating in this study:
- 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.
- Inability or unwillingness to perform OLE therapy or study procedures as required.
See the full eligibility criteria
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- 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.
- Bronchiectasis diagnosis (including patients with cystic fibrosis with documented bronchiectasis).
- Signed informed consent (and Child assent if minor subject).
- An individual who meets any of the following criteria will be excluded from participating in this study:
- 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.
- Inability or unwillingness to perform OLE therapy or study procedures as required.
- Currently enrolled in a different study.
- Current smoker or tobacco use within the last 30 days.
- Pregnancy or Breastfeeding.
- 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...
- Inability to comply with the treatment protocol or study procedures.
- Known allergies to materials used in OLE device.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Orlando, Florida, United States
- Port Saint Lucie, Florida, United States
- Tamarac, Florida, United States
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Orlando, Florida, United States; Port Saint Lucie, Florida, United States; Tamarac, Florida, United States; Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.