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A Clinical Evaluation of the RheOx™ Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD

Study Type/Phase: Interventional
Enrollment Status: Recruiting

Chronic Obstructive Pulmonary Disease (COPD) 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 is a common clinical presentation in COPD and is classically defined as chronic cough and sputum production for 3 months per year in each of 2 successive years. According to the US Centers for Disease Control and Prevention, chronic bronchitis affects approximately 9 million people, up to 22% of adults in the United States, almost half of whom are between 44 and 65 years of age.

The RheOx™ System is an investigational treatment intended for patients with chronic bronchitis. It is believed that the symptoms of chronic bronchitis, which are mainly cough and phlegm (mucus) production, are associated with abnormal mucus cells in the bronchi (airway passages) of the lungs.

Bronchial Rheoplasty is delivered through the RheOx™ System. It consists of the RheOx™ generator that produces short pulsed electrical fields (low electrical energy) and the RheOx™ Catheter. Bronchial Rheoplasty is designed to remove the tissue layers of the airway where the abnormal mucus cells are located. It is expected the airway tissue will heal more normally after treatment, and thereby reduce the symptoms associated with chronic bronchitis, such as cough and phlegm.

This is a randomized study to evaluate the safety and effectiveness of the RheOx System developed for patients with chronic bronchitis. This device has not been approved by the U.S. Food and Drug Administration (FDA).

About 270 subjects will take part in this study. Approximately 40 subjects may take part in this study at El Camino Health.

Principal Investigator

Ganesh Krishna, MD

Sponsor

Gala Therapeutics, Inc.

NCT Number

NCT03631472

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

 

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