Post-market clinical study (registry study) to collect post-market safety and clinical utility data in European patients with chronic bronchitis treated with RheOx.
RheOx is a device-based, energy delivery system that delivers high frequency short duration energy to 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 anaesthesia. 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 to several tests and questionnaires during the study including respiratory function tests.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
RheOX is a CE-marked 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.
Otto Wagner Spital
Vienna, Austria
RECRUITINGPneumologie Thoraxklinik Heidelberg gGmbH University of Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
RECRUITINGSafety: Incidence of SAEs
Incidence of serious adverse events associated with RheOx treatment through 24 months
Time frame: Through end of study (24 months post bilateral treatment)
Quality of Life: CAT
COPD Assessment Test (CAT) questionnaire
Time frame: Through end of study (24 months post bilateral treatment)
Quality of Life: SGRQ
St. George Respiratory Questionnaire
Time frame: Through end of study (24 months post-bilateral treatment)
Pulmonary Function: FEV1
Forced expiratory volume (FEV). FEV1 is the amount of air you can force from your lungs in one second.
Time frame: Through end of study (24 months post-bilateral treatment)
Pulmonary Function: FVC
Forced Vital Capacity
Time frame: Through end of study (24 months post-bilateral treatment)
COPD Exacerbations
COPD Exacerbations
Time frame: Through end of study (24 months post-bilateral treatment)
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