A Feasibility Study: A Safety Evaluation of the Gala Airway Treatment System on Patients with Chronic Bronchitis in Australia

The Gala Therapeutics Airway Treatment System for Chronic Bronchitis in Australia will evaluate the safety and efficacy of the technology in up to 24 adult patients across three sites in Australia, Patients with chronic bronchitis for a minimum of 2 years will be enrolled. Patients with a history of pacemaker / implantable defibrillator and cardiac arrhythmias as well as prior lung surgery, such as lung transplant, LVRS, lung implant/prosthesis, metal stent, valves, coils, bullectomy, segmentectomy, or lobectomy will not be considered for the trial Exception to this is patients who have had a valve removed greater than 30 days prior to being enrolled in the trial provided that the airway is sufficiently accessible for the Gala treatment.. The trial is single arm / non randomised (it is intended that each patient enrolled in the trial will receive the treatment under investigation) and is non blinded (patients and clinicians will be aware that the treatment is being delivered). The trial will subject consented participants to treatment by the Gala Therapeutics Airway Treatment system over 2 bronchoscopies that will be performed by trained respiratory physicians (interventional pulmonologists) in tertiary teaching hospitals. Patients will be anaesthetised for these procedures. A third bronchoscopy will be performed in order to take airway biopsies to assess the effect of the treatment on the cells that produce mucous in the airways. Subjects will also be required to undertake several tests during the study including 2 CT scans (Lung), respiratory function tests, exercise testing and blood tests. Subjects will be followed for 1 year following the second bronchoscopy.