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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 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.

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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.

Conditions Studied

Chronic Bronchitis

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

FieldValue
Enrollment Target 210 participants
Start Date 2020-07-09
Est. Completion 2026-09
Phase NA

Sponsor

CSA Medical

9 total trials

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What the Registry Record Tells You About NCT03893370

The ClinicalTrials.gov registry entry for NCT03893370 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 10,253-participant average among 8 other Chronic Bronchitis trials with a reported enrollment target (98% lower). The listed sponsor is CSA Medical, which has 9 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.