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NCT03893370 · ClinicalTrials.gov registry record · NA
RejuvenAir® System Trial for COPD With Chronic Bronchitis
A NA study of Chronic Bronchitis, sponsored by CSA Medical.
- Active
- Registry status
- NA
- Development phase
- 210
- Enrollment target
- 20
- Study locations
NCT03893370: Active NA study of Chronic Bronchitis, sponsored by CSA Medical.
NCT03893370 is a NA study of Chronic Bronchitis that is active but no longer recruiting, run by CSA Medical. The registered enrollment target is 210 participants, below the 10,253-participant average among 8 other Chronic Bronchitis trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03893370, a NA study of Chronic Bronchitis, is active but no longer recruiting, sponsored by CSA Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 210 participants
- Enrollment target
- 20
- Study locations
Study Summary
Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB) is a common clinical phenotype within the umbrella of a COPD diagnosis and is classically defined as chronic cough and sputum production for 3 months a year for 2 consecutive years2, but many studies have used different definitions to define it- chronic cough and sputum production for one year or cough and sputum production on most days of the week. CB is associated with multiple clinical consequences, including; the worsening of lung function decline, increasing risk of acute exacerbations of COPD, increased risk of developing pneumonia, reduced health related quality of life, and an increase in all-cause mortality.
Primary Outcome
Change in St. George Respiratory Questionnaire (SGRQ) score from Baseline to 12 months
Conditions Studied
Interventions
- DEVICE RejuvenAir System
- DEVICE Sham Control Procedure
Study Locations (20)
Ohio
- University Of Cincinnati - Cincinnati
- The Cleveland Clinic Foundation - Cleveland
- The Ohio State Universisty - Columbus
California
- El Camino Hospital - Mountain View
- University of California, Davis Medical Center - Sacramento
Florida
- Advanced Pulmonary Research Institute - Loxahatchee Groves
- Sarasota Memorial Hospital - Sarasota
Maryland
- University of Maryland - Baltimore
- Johns Hopkins Universtiy - Baltimore
Michigan
- Henry Ford Health System - Detroit
- Spectrum Health - Grand Rapids
Pennsylvania
- Clinical Research Associates of Central PA - Altoona
- Temple University - Of the Commonwealth System of Higher Education - Philadelphia
Arizona
- Honor Health - Scottsdale
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2020-07-09 |
| Est. Completion | 2026-09 |
| Phase | NA |
What the registry record for NCT03893370 still lists
NCT03893370 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 10,253-participant average among 8 other Chronic Bronchitis trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Chronic Bronchitis appearing as the primary indexed condition, and to 2 interventions - of which RejuvenAir System is the first listed.
NCT03893370 names 20 study sites across 13 states, led by Ohio, California, Florida.
Frequently Asked Questions
What is clinical trial NCT03893370 about?
NCT03893370 is a clinical study titled "RejuvenAir® System Trial for COPD With Chronic Bronchitis". Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB) is a common clinical phenotyp...
What is the current status of trial NCT03893370?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 210 participants. The study started on 2020-07-09. Estimated completion is 2026-09.
What conditions does trial NCT03893370 study?
This clinical trial studies the following conditions: Chronic Bronchitis.
What interventions are being tested in trial NCT03893370?
The interventions under investigation include: RejuvenAir System (DEVICE), Sham Control Procedure (DEVICE).
Who is sponsoring clinical trial NCT03893370?
This trial is sponsored by CSA Medical, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03893370 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Bronchitis
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Where NCT03893370's enrollment target sits among peer trials
210 5th of 8 higher than 4 of 8 other Chronic Bronchitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Bronchitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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