NCT06926881 OLE Therapy With BE Patients in Home Care Study
| NCT ID | NCT06926881 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Delve Health |
| Condition | Bronchiectasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 85 participants in total. It began in 2025-05-20 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06926881 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, studying Bronchiectasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06926881 currently recruiting?
Yes, NCT06926881 is actively recruiting participants. Contact the research team at tdahl@delvehealth.com for enrollment information.
Where is the NCT06926881 trial being conducted?
This trial is being conducted at New Haven, United States, Orlando, United States, Port Saint Lucie, United States, Tamarac, United States and 1 additional location.
Who is sponsoring the NCT06926881 clinical trial?
NCT06926881 is sponsored by Delve Health. The trial plans to enroll 85 participants.