OLE Therapy With BE Patients in Home Care Study

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Delve Health
Study ID
NCT06926881
Status
Recruiting
Apply to this trial

Conditions

  • Bronchiectasis
  • Pulmonary Exacerbation

Eligibility Criteria

Sex
ALL
Age
5 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BiWaze Clear System — DEVICE
    The BiWaze Clear device includes several components as follows: 1. BiWaze Clear System. 2. BiWaze Clear Dual Lumen Breathing Circuit. * Dual Lumen bacterial/viral filter. * Dual Lumen breathing tube. * Patient Interface (Anesthesia mask \[small, medium or large\], Mouthpiece, or trach adapter). 3. Carrying Bag. The patient will perform airway clearance therapy with the BiWaze Clear System

Study Details

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.

Key Dates

Start date
May 20, 2025
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
85 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BiWaze Study Device treatment single Arm
    All patients will be assigned to a single treatment arm utilizing BiWaze Clear System

Primary Outcome Measure

Evaluate the effectiveness of BiWaze Clear therapy in reducing the frequency of pulmonary exacerbations and improving clinical outcomes. [ Time Frame: 6 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Yale School of MedicineNew HavenConnecticut06510
Ashley Losier
[email protected]
203-432-4771
Central Florida Pulmonary Group, P.A.OrlandoFlorida32803
Daniel T. Layish, MD,FACP,FCCP,FAASM
[email protected]
407-841-1100
Wilma Uy, RN, CRC
[email protected]
(407) 841-1100
Treasure Coast Medical Research Group, LLCPort Saint LucieFlorida34986
Mark Pamer, MD
[email protected]
7727855864
Nicole Trujillo, CRC
[email protected]
7727855864
Metropolitan Clinical ResearchTamaracFlorida33321
Hector Vazquez, MD
[email protected]
(954) 569 - 6820
Osmani Placencia, MD
[email protected]
(954) 569 - 6820.
University of South Florida -Tampa General HospitalTampaFlorida33612
Chak Sriaroon, MD
[email protected]
813 810 5700
Gabriel Parker, PM
[email protected]
813 810 5700

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Yale School of Medicine· New Haven, CTCentral Florida Pulmonary Group, P.A.· Orlando, FLTreasure Coast Medical Research Group, LLC· Port Saint Lucie, FLMetropolitan Clinical Research· Tamarac, FLUniversity of South Florida -Tampa General Hospital· Tampa, FL

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