An early feasibility study (EFS) to assess the safety and clinical utility of RheOx on patients with chronic bronchitis in the United States.
RheOx is a device-based, energy delivery system that delivers energy for the ablation of soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope. Two sessions of treatment will be delivered one month apart. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session (approximately one month after the right side is treated). Treatment will be delivered by a respiratory physician (interventional pulmonologist) in a tertiary teaching hospital during a bronchoscopic procedure. The bronchoscopy will be delivered during general anesthesia. It is anticipated that the bronchoscopic procedure will last less than 60 minutes in total. Treatment will be deemed to have been delivered following the successful treatment during the two bronchoscopies. Subjects will be required to submit tests during the study including three CT scans (lung), respiratory function tests, exercise testing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
RheOx is a device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.
University of Alabama Lung Health Center
Birmingham, Alabama, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
University of Chicago
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Safety Through 12 Months: Rate of Serious Adverse Events
Rate of serious adverse events of interest through 12 months. Events of interest are death, COPD exacerbation requiring hospitalization, pneumothrax within 2 days of procedure, pneumonia within 7 days of procedure, respiratory failure or arrhythmia requiring intervention.
Time frame: 12 months
Clinical Utility: SGRQ Score at 6 Months
The change from baseline to 6 months in St. George's Respiratory Questionnaire (SGRQ) total score.
Time frame: 6 months
Clinical Utility: SGRQ Score at 12 Months
The change from baseline to12 months in St. George's Respiratory Questionnaire (SGRQ) total score
Time frame: 12 months
Clinical Utility: CAT Total Score at 6 Months
The change from baseline to 6 months in COPD Assessment Test (CAT) total score
Time frame: 6 months
Clinical Utility: CAT Total Score at 12 Months
The change from baseline to 12 months in COPD Assessment Test (CAT) total score
Time frame: 12 months
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MedStar Health
Baltimore, Maryland, United States
Beth Israel Deaconess
Boston, Massachusetts, United States
Temple University School of Medicine
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States