OLE Therapy With BE Patients in Home Care Study

NCT06926881 | Recruiting FDA Device

• 1 other identifier: BiWaze Clear_001
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 5

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.

Conditions

Bronchiectasis; Pulmonary Exacerbation

Outcome Measures

Primary Outcomes (1)

• Evaluate the effectiveness of BiWaze Clear therapy in reducing the frequency of pulmonary exacerbations and improving clinical outcomes.

  Quantify the frequency of pulmonary exacerbations over a 6-month period during BiWaze Clear therapy and compare this data to the number of exacerbations recorded in the 12 months prior to the initiation of therapy.

  6 months

Study Arms (1)

BiWaze Study Device treatment single Arm

EXPERIMENTAL

All patients will be assigned to a single treatment arm utilizing BiWaze Clear System

Device: BiWaze Clear System

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

BiWaze Study Device treatment single Arm

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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 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).

You may not qualify 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.
• 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 conditions.
• Inability to comply with the treatment protocol or study procedures.
• Known allergies to materials used in OLE device.

Sponsors & Collaborators

• Delve Health: lead

Study Sites (5)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

RECRUITING

Central Florida Pulmonary Group, P.A.

Orlando, Florida, 32803, United States

RECRUITING

Treasure Coast Medical Research Group, LLC

Port Saint Lucie, Florida, 34986, United States

RECRUITING

Metropolitan Clinical Research

Tamarac, Florida, 33321, United States

RECRUITING

University of South Florida -Tampa General Hospital

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Central Study Contacts

Theresa Dahl, Master Clinical Pathology

CONTACT

952-200-6228; tdahl@delvehealth.com

Wessam Sonbol, CEO

CONTACT

16123969538; wsonbol@delvehealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patient will perform airway clearance therapy with the BiWaze Clear System The BiWaze Clear device includes several components : 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.

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 15, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Q3-2026

Locations

US (5)