BiWaze Clear System for Bronchiectasis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a device called BiWaze Clear to evaluate its effectiveness in helping people with bronchiectasis breathe better. The device employs a therapy known as Oscillating Lung Expansion (OLE) to loosen mucus and expand the lungs. Participants will use the BiWaze Clear system instead of their usual airway clearance therapy for six months. Suitable candidates have a bronchiectasis diagnosis and have experienced at least one respiratory flare-up requiring medical attention in the past six months. As an unphased trial, this study provides participants the chance to explore a new therapy that could enhance their breathing and quality of life.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, you will use the BiWaze Clear system for airway clearance instead of your previous therapy.
What prior data suggests that the BiWaze Clear System is safe for patients with Bronchiectasis?
Research shows that patients generally find the BiWaze Clear System easy to use. The FDA has approved the system, confirming its safety for treating other breathing problems. Studies have gathered safety information over six months, closely monitoring and reporting any side effects. So far, no serious problems related to its use have been reported. This suggests that the treatment is safe for people with breathing issues like bronchiectasis, a lung condition causing a persistent cough and mucus. While no treatment is entirely risk-free, the available data supports BiWaze Clear as a safe choice for those seeking help with their breathing.12345
Why are researchers excited about this trial?
Researchers are excited about the BiWaze Clear System for bronchiectasis because it offers a new way to manage symptoms through advanced airway clearance technology. Unlike traditional treatments like antibiotics and physical therapy, the BiWaze Clear System uses a unique device that helps clear mucus more effectively from the lungs. This device aims to improve lung function and reduce the frequency of respiratory infections, promising a better quality of life for patients with bronchiectasis.
What evidence suggests that the BiWaze Clear system is effective for bronchiectasis?
Research has shown that the BiWaze Clear system can assist individuals with bronchiectasis. Studies have found it reduces lung flare-ups, supports lung expansion, and helps loosen mucus, making breathing easier. The system combines lung therapy with gentle shaking and can provide extra oxygen if needed. The FDA has approved it, indicating it meets safety standards for respiratory therapy. In this trial, all participants will receive treatment using the BiWaze Clear System.12345
Are You a Good Fit for This Trial?
This trial is for people aged 5-85 with Bronchiectasis who've had at least one unplanned medical intervention due to respiratory issues in the last 6 months, or two in the past year. Participants must be able to use BiWaze Clear as prescribed and have signed consent forms.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline assessment including vital signs, respiratory rate, oxygen saturation, and other initial measurements
Treatment
Participants receive BiWaze Clear therapy for airway clearance, with regular monitoring and assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- OLE Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Delve Health
Lead Sponsor
ABM Respiratory Care
Collaborator