Feasibility trial (FIH) to assess the safety and clinical utility in patients with chronic bronchitis.
The Gala Airway Treatment system 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. A third bronchoscopy will be performed three months following the second treatment session where treatment is not delivered but a cryo-biopsy will be taken from the airway sites that have been treated during the two previous bronchoscopic treatment session to evaluate the effect of the treatment on the airways producing excessive mucous. Subjects will be required to submit to several tests during the study including two CT scans (lung), respiratory function tests, exercise testing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
18
The Gala Airway Treatment system 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. In this study, 2 treatment sessions will be delivered 1 month apart. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session. A third bronchoscopy will be performed 3 months following the second treatment session where treatment is not delivered but a cryo-biopsy will be taken from the airway sites that have been treated during the two previous bronchoscopic treatment session to evaluate the effect of the treatment on the airways producing excessive mucous. Subjects will be required to submit to several tests during the study including two CT scans (lung), respiratory function tests, exercise testing.
Otto Wagner Spital
Vienna, Austria
Clinica Alemana
Santiago, Chile
Safety: Incidence and evaluation of any serious adverse events associated with the Gala Airway Treatment System through 6 months.
Incidence and evaluation of any serious adverse events associated with the Gala Airway Treatment System through 6 months.
Time frame: 6 months
Clinical Utility - Histology
Histopathological evidence of change in mucus producing cells within the airway.
Time frame: 3 months following bilateral treatment
Clinical Utility - Pulmonary Function
Pulmonary function testing (PFT) utilizing Forced Expiratory Volume (FEV1)
Time frame: Through end of study (12-months post-bilateral treatment)
Quality of Life - COPD Assessment Test (CAT)
COPD Assessment Test (CAT) questionnaire
Time frame: Through end of study (12-months post-bilateral treatment)
Quality of Life - SGRQ
Patient filled respiratory questionnaire: St. George Respiratory Questionnaire (SGRQ)
Time frame: Through end of study (12-months post-bilateral treatment)
Acute Exacerbations
Detection of acute exacerbations (measured by clinical examination of a suitably qualified physician)
Time frame: From 48 hours post procedure through end of study (12 months post-bilateral treatment)
Non-Acute Exacerbations
Detection of non-acute exacerbations (measured by clinical examination of a suitably qualified physician)
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Time frame: From 48 hours post procedure through end of study (12 months post-bilateral treatment)
Six Minute Walk Test (6MWT)
Change in 6MWT at 6 months compared to baseline
Time frame: 6 months post-bilateral treatment