Gala Treatment for Chronic Bronchitis in Canada

NCT03385616 | Completed FDA Device

• 1 other identifier: CS004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

Feasibility trial (FIH) to assess the safety and clinical utility in patients with chronic bronchitis in Canada.

Conditions

Chronic Bronchitis; COPD

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence of serious adverse events associated with the Gala Airway Treatment System through 6 months.

  Incidence of serious adverse events associated with the Gala Airway Treatment System through 6 months.

  6 months

Secondary Outcomes (7)

• Clinical Utility - Histology

  3 months following bilateral treatment

• Clinical Utility - Pulmonary Function

  Through end of study (12-months post-bilateral treatment)

• Quality of Life - CAT

  Through end of study (12-months post-bilateral treatment)

• Quality of Life - SGRQ

  Through end of study (12-months post-bilateral treatment)

• Acute Exacerbations

  From 48 hours post procedure through end of study (12 months post-bilateral treatment)

Other Outcomes (1)

• CASA-Q

  Through end of study (12 months post-bilateral treatment)

Study Arms (1)

Treatment with GATS

EXPERIMENTAL

Gala Airway Treatment System (GATS)

Device: Gala Airway Treatment System

Interventions

Gala Airway Treatment System DEVICE

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.

Also known as: GATS

Treatment with GATS

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is diagnosed with chronic bronchitis for a minimum of two years, where chronic bronchitis is defined clinically as chronic productive cough for three months in each of two successive years in a patient in whom other causes of productive cough have been excluded.
• Subject has GOLD Stage II chronic obstructive pulmonary disease (COPD) with a preprocedure post-bronchodilator FEV1 of greater than or equal to 30% and less than or equal to 80% of predicted within three months of enrollment.
• Subject has an FEV1/FVC ration \< 0.7.
• Subject has been treated with Long Acting Beta Agonists (LABAs) or Long Acting Muscarinic Antagonists (LAMAs) or both for three months or more.
• Subject has a cigarette smoking history of at least ten packs years.
• Subject in the opinion of the site investigator is able to adhere to and undergo three bronchoscope procedures inclusive of lung biopsies and Gala treatments, and has provided a signed informed consent.

You may not qualify if:

• Subject has active respiratory infection (e.g., common cold, pneumonia, MAI, tuberculosis) or COPD exacerbation within the last three months.
• Subject has MMRC score greater than or equal to 3.
• Subject is taking \> 10 mg of prednisolone or prednisone per day.
• Subject has an implantable cardioverter defibrillator or pacemaker.
• Subject has a history of cardiac arrhythmia within past two years.
• Subject has abnormal cardiac rhythm at time of procedure.
• Subject has history of proven lung cancer in last 5 years.
• Subject has pulmonary nodule or cavity requiring follow-up or intervention unless proven benign and not actively infected (e.g., aspergilloma).
• Subject has prior lung surgery, such as lung transplant, LVRS, lung implant/prosthesis, metal stent, valves, coils, bullectomy, segmentectomy, or lobectomy. Pneumothorax without lung resection is acceptable. Pleural procedures without surgery are acceptable.
• Subject has Alpha-1-Antitrypsin (AAT) deficiency.
• Subject has documented history of asthma diagnosed with onset \<30 years of age, clinically significant bronchiectasis or any other significant second lung disease.
• Subject actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
• Subject has known airway colonization with resistant organisms including but not limited to pseudomonas, MRSA, B Cepacia, MTB, M abscessus, mucor or any significant fungus.
• Subject has the inability to walk over 140 meters.
• Subject has a serious medical condition, such as: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction in the past year, renal failure, liver disease, cerebrovascular accident within the past 6 months, uncontrolled diabetes, hypertension, autoimmune disease or uncontrolled gastric reflux.

Sponsors & Collaborators

• Gala Therapeutics, Inc.: lead

Study Sites (3)

St. Paul's Hospital Vancouver Centre for Heart Lung Innovation

Vancouver, British Columbia, V6Z 1Y7, Canada

Location

Notre Dame Hospital at CHUM

Montreal, H2L 4M1, Canada

Location

IUCPQ Quebec

Québec, G1V 4G5, Canada

Location

Related Publications (1)

• Krimsky WS, Mammarappallil JG, Kim V, Bannan B, Charbonnier JP, Hatton BA, Sciurba FC. Airway Mucus Plugging in Chronic Bronchitis and the Impact of Bronchial Rheoplasty. Chest. 2026 Jan;169(1):73-83. doi: 10.1016/j.chest.2025.06.022. Epub 2025 Jun 24.

  PMID: 40571054 DERIVED

MeSH Terms

Conditions

Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William Krimsky, MD

  Gala Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment with Gala Airway Treatment System

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 28, 2017
• Study Start: August 24, 2017
• Primary Completion: July 30, 2020
• Study Completion: February 28, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)