MedTrace Logo

OLE Therapy With BE Patients in Home Care Study

NCT06926881 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2026-04-14

No results posted yet for this study

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

Interventions

DEVICE

BiWaze Clear System

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

Sponsors & Collaborators

  • Delve Health

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-20
Primary Completion
2026-05-31
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06926881 on ClinicalTrials.gov