OLE Therapy With BE Patients in Home Care Study
A legfontosabb adatok
- Hol
- New Haven, Orlando, Port Saint Lucie, Tamarac és Tampa (Egyesült Államok)Mind a 5 helyszín megnézése
Helyszínek itt: Egyesült Államok
- Yale School of MedicineNew Haven, Egyesült ÁllamokContact: Ashley LosierRésztvevőt keres
- Central Florida Pulmonary Group, P.A.Orlando, Egyesült ÁllamokContact: Daniel T. Layish, MD,FACP,FCCP,FAASMRésztvevőt keres
- Treasure Coast Medical Research Group, LLCPort Saint Lucie, Egyesült ÁllamokContact: Mark Pamer, MDRésztvevőt keres
- Metropolitan Clinical ResearchTamarac, Egyesült ÁllamokContact: Hector Vazquez, MDRésztvevőt keres
- University of South Florida (Tampa General Hospital)Tampa, Egyesült ÁllamokContact: Chak Sriaroon, MDRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Delve Health
- Azonosító
- NCT06926881
- A regiszteradat frissítve
- 2026. április 14.
- Eredeti leírás
The study will examine how the performance of Oscillating Lung Expansion (OLE) therapy affects the respiratory health of patients with Bronchiectasis (BE).A teljes eredeti leírásKevesebb
Oscillating Lung Expansion (OLE) Therapy in the Bronchiectasis Patients (BE) Home Care Study Protocol
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.
Bevonási feltételek: 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).
Kizáró feltételek: Use of OLE therapy within the past 12 months; Inability or unwillingness to perform OLE therapy or study procedures as required; History of pneumothorax within the past 6 months; 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; Known allergies to materials used in OLE device; 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; Currently enrolled in a different study; Current smoker or tobacco use within the last 30 days; Pregnancy or Breastfeeding; Inability to comply with the treatment protocol or study procedures.