Gala Treatment for Chronic Bronchitis in Canada
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03385616|
Recruitment Status : Recruiting
First Posted : December 28, 2017
Last Update Posted : February 19, 2019
|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)|
|Estimated Enrollment :||24 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|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||July 30, 2020|
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 - Pulmonary Function [ Time Frame: Pulmonary function FEV1 measured at 1week, 3 months, 6 months and 12 months post treatment number 2 ]Pulmonary function testing utilizing the FEV1
- Clinical Utility - CAT Quality of Life [ Time Frame: CAT will be completed at baseline, at treatment 2, 3 months, 6 months and 12 months post treatment 2 ]COPD Assessment Test (CAT) questionnaire
- Clinical Utility - SGRQ Quality of Life [ Time Frame: SGRQ will be completed at baseline, at treatment 2, 3 months, 6 months and 12 months post treatment 2 ]QOL will be measured using the St. George Respiratory Questionnaire (SGRQ)
- Acute Exacerbations [ Time Frame: Between 48 hours post procedure (1st or 2nd treatment procedures and 3rd biopsy procedure) and the end of the patient's participation in the study (up to 1 year following final treatment session) ]Detection of acute exacerbations (measured by clinical examination of a suitably qualified physician)
- Histology [ Time Frame: 3 months post final treatment procedure ]Histopathological evidence of reduction in mucus producing cells within the airway
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
|Contact: Brett Bannonfirstname.lastname@example.org|
|Canada, British Columbia|
|Notre Dame Hospital at CHUM||Recruiting|
|Montreal, British Columbia, Canada, H2L 4M1|
|Contact: Vicky Thiffault 514-890-8000 ext 23432 email@example.com|
|Principal Investigator: Abraham M Liberman, MD|
|St. Paul's Hospital Vancouver Centre for Heart Lung Innovation||Recruiting|
|Vancouver, British Columbia, Canada, V6Z 1Y7|
|Contact: Tara Martin 604-499-3306 firstname.lastname@example.org|
|Principal Investigator: Delbert Dorscheid, MD|
|Quebec, Canada, G1V 4G5|
|Contact: Josee Picard 418-656-8711 ext 2934 email@example.com|
|Principal Investigator: Simon Martel, MD|
|Study Director:||William Krimsky, MD||Gala Therapeutics, Inc.|