RECRUITING

OLE Therapy With BE Patients in Home Care Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Oscillating Lung Expansion (OLE) Therapy in the Bronchiectasis Patients (BE) Home Care Study Protocol

Quick Facts

Study Start:2025-05-20
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06926881

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients aged 5 to 85 years old.
  2. 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. 3. Ability to perform BiWaze Clear therapy as prescribed.
  4. 4. Bronchiectasis diagnosis (including patients with cystic fibrosis with documented bronchiectasis).
  5. 5. Signed informed consent (and Child assent if minor subject).
  1. 1. Diagnosis with rapidly progressing NMD.
  2. 2. Post bronchodilator FEV₁ ≥ 65 % predicted
  3. 3. Anticipated requirement for hospitalization within the next six months.
  4. 4. History of pneumothorax within the past 6 months.
  5. 5. Use of OLE therapy within the past 12 months.
  6. 6. Inability or unwillingness to perform OLE therapy or study procedures as required.
  7. 7. Currently enrolled in a different study.
  8. 8. Current smoker or tobacco use within the last 30 days.
  9. 9. Pregnancy or Breastfeeding.
  10. 10. 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.
  11. 11. Inability to comply with the treatment protocol or study procedures.
  12. 12. Known allergies to materials used in OLE device.

Contacts and Locations

Study Contact

Ola CRM, Master Clinical Pathology
CONTACT
952-200-6228
osoliman@delvehealth.com
Wessam Sonbol, CEO
CONTACT
16123969538
wsonbol@delvehealth.com

Study Locations (Sites)

Central Florida Pulmonary Group, P.A.
Orlando, Florida, 32803
United States
Treasure Coast Medical Research Group, LLC
Port Saint Lucie, Florida, 34986
United States
Metropolitan Clinical Research
Tamarac, Florida, 33321
United States
University of South Florida -Tampa General Hospital
Tampa, Florida, 33612
United States

Collaborators and Investigators

Sponsor: Delve Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-20
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2025-05-20
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Bronchiectasis
  • Pulmonary Exacerbation