Status:
TERMINATED
A Pilot Study to Evaluate the Use of the Vest® System for Treatment of Bronchiectasis Patients in the Home Setting
Lead Sponsor:
Hill-Rom
Conditions:
Bronchiectasis
Bronchiectasis With Acute Exacerbation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This a 70 patient multi-site non blinded randomized control trial evaluating the use of the Vest® System for treatment of Non-Cystic Fibrosis Bronchiectasis (NCFBE) patients in the home setting. The s...
Detailed Description
Patients with NCFBE who require regular home airway clearance therapy will be eligible to be screened for inclusion in the study. After enrollment, baseline data including demographics, pulmonary rel...
Eligibility Criteria
Inclusion
- Radiological diagnosis of Bronchiectasis based on high resolution chest CT scan
- History of at least 2 acute exacerbations or hospitalizations in the past 12 months
- Clinically stable for \>2 weeks prior to study entry
- FEV1 \>30% predicted
- Age18-80 years
- Signed informed consent
Exclusion
- Diagnosis of Cystic Fibrosis
- History of bronchiectasis secondary to primary immunodeficiency
- Active pulmonary tuberculosis
- Active treatment of Non-Tuberculous Mycobacterium (NTM)
- Patients currently on home HFCWO treatment or home HFCWO treatment within the past 24 months
- Diagnosed comorbidity or medical indication that would prevent study completion
- History of pneumothorax within past 6 months
- History of hemoptysis requiring embolization within past 12 months
- Inability to perform HFCWO therapy or OPEP therapy as directed
- Pregnancy or lactation
- Inability or unwillingness to complete study visits or provide follow-up data as required by the study protocol
Key Trial Info
Start Date :
August 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2024
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04017312
Start Date
August 23 2019
End Date
August 6 2024
Last Update
August 21 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
NYU Langone Health
New York, New York, United States, 10016
2
Tennessee Comprehensive Lung and Sleep Center
Nashville, Tennessee, United States, 37075
3
UT Tyler Health Science Center
Tyler, Texas, United States, 75708