NCT04271969

Clinical Effectiveness Of High Frequency Chest Wall Oscillation (HFCWO) In A Bronchiectasis Population

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Electromed, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to compare the patient's baseline QoL prior to HFCWO use against the patient's QoL at various study timepoints over a one-year period of HFCWO use.

Detailed description

This study will use a prospective interventional comparative study design using the patient's quality of life (QoL) as the primary study endpoint to determine HFCWO affect. The study will compare the patient's QoL baseline (established at enrollment prior to HFCWO treatment) to the QoL measured at various timepoints (enrollment, 2 months, 6 months and 12 months) over a one-year period whilst receiving HFCWO treatment. In addition, a baseline for the secondary endpoints will established at enrollment for comparison to measurements taken at various timepoints over a one-year period whilst receiving HFCWO treatment. The patient's medical records will be used to establish prior histories of exacerbation rates for comparison to exacerbation rates experienced after one year of HFCWO treatment. Patients will serve as their own control.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
DEVICE	SmartVest Airway Clearance System	Pulmonary airway clearance of retained mucus via high frequency chest wall oscillation (SmartVest)

Timeline

• Start date: 2020-02-18
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2020-02-17
• Last updated: 2023-12-07

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study