Gala Treatment for Chronic Bronchitis in Canada
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|ClinicalTrials.gov Identifier: NCT03385616|
Recruitment Status : Completed
First Posted : December 28, 2017
Last Update Posted : August 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Bronchitis COPD||Device: Gala Airway Treatment System||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Treatment with Gala Airway Treatment System|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||A Feasibility Study: A Safety Evaluation of the Gala Airway Treatment System on Patients With Chronic Bronchitis in Canada|
|Actual Study Start Date :||August 24, 2017|
|Actual Primary Completion Date :||July 30, 2020|
|Actual Study Completion Date :||February 28, 2021|
Experimental: Treatment with GATS
Gala Airway Treatment System (GATS)
Device: Gala Airway Treatment System
The Gala Airway Treatment system 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.
Other Name: GATS
- Safety: Incidence of serious adverse events associated with the Gala Airway Treatment System through 6 months. [ Time Frame: 6 months ]Incidence of serious adverse events associated with the Gala Airway Treatment System through 6 months.
- Clinical Utility - Histology [ Time Frame: 3 months following bilateral treatment ]Histopathological evidence of change in mucus producing cells within the airway
- Clinical Utility - Pulmonary Function [ Time Frame: Through end of study (12-months post-bilateral treatment) ]Pulmonary function testing (PFT) utilizing Forced Expiratory Volume (FEV1)
- Quality of Life - CAT [ Time Frame: Through end of study (12-months post-bilateral treatment) ]COPD Assessment Test (CAT) questionnaire
- Quality of Life - SGRQ [ Time Frame: Through end of study (12-months post-bilateral treatment) ]St. George Respiratory Questionnaire (SGRQ)
- Acute Exacerbations [ Time Frame: From 48 hours post procedure through end of study (12 months post-bilateral treatment) ]Detection of acute exacerbations (measured by clinical examination of a suitably qualified physician)
- Non-Acute Exacerbations [ Time Frame: From 48 hours post procedure through end of study (12 months post-bilateral treatment) ]Detection of non-acute exacerbations (measured by clinical examination of a suitably qualified physician)
- Six Minute Walk Test [ Time Frame: 6 months post-bilateral treatment ]Change in 6MWT at 6 months compared to baseline
- CASA-Q [ Time Frame: Through end of study (12 months post-bilateral treatment) ]Patient reported outcome respiratory questionnaire: Cough and Sputum Assessment Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385616
|Canada, British Columbia|
|St. Paul's Hospital Vancouver Centre for Heart Lung Innovation|
|Vancouver, British Columbia, Canada, V6Z 1Y7|
|Notre Dame Hospital at CHUM|
|Montreal, Canada, H2L 4M1|
|Quebec, Canada, G1V 4G5|
|Study Director:||William Krimsky, MD||Gala Therapeutics, Inc.|