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

NCT ID: NCT04271969

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-18

Study Completion Date

2023-12-01

Brief Summary

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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

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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

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Bronchiectasis

Keywords

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HFCWO Bronchiectasis SmartVest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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SmartVest Airway Clearance System

Pulmonary airway clearance of retained mucus via high frequency chest wall oscillation (SmartVest)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 18 years of age or older
2. Previous diagnosis of bronchiectasis confirmed by HRCT within the last 6 months
3. Patients must have at least 6 months of medical records related to bronchiectasis
4. Patients must be stable and currently on a standard of care regimen for bronchiectasis such as hypertonic saline and/or PEP
5. Patients with 1 or more exacerbations within the last 12 months
6. Previous and existing productive cough
7. No previous HFCWO use

Exclusion Criteria

1. Patients who are known to have cystic fibrosis
2. Patients who are known to have primary ciliary dyskinesia (PCD)
3. Patients with chronic obstructive pulmonary disease (COPD) without bronchiectasis
4. Patients breathing via an artificial airway
5. Severe bronchospasm based on exam or history
6. Any comorbidity(ies) or contraindications that would normally complicate tolerating HFCWO treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Electromed, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George Solomon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama - Birmingham (UAB University Hospital)

Birmingham, Alabama, United States

Site Status

Emory University School of Medicine

Atlanta, Georgia, United States

Site Status

Temple University

Philadelphia, Pennsylvania, United States

Site Status

The University of Texas Health Science Center at Tyler

Tyler, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HFCWO-001

Identifier Type: -

Identifier Source: org_study_id