Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-04-23 @ 4:17 PM
Study NCT ID:
NCT03107494
Status:
COMPLETED
Last Update Posted:
2020-09-01
First Post:
2017-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gala FIH Feasibility Study for the Treatment of Chronic Bronchitis
Sponsor:
Gala Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Feasibility Study: A Safety Evaluation of the Gala Airway Treatment System on Patients With Chronic Bronchitis
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Feasibility trial (FIH) to assess the safety and clinical utility in patients with chronic bronchitis.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: