Clinical Trial: Gala FIH Feasibility Study for the Treatment of Chronic Bronchitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Feasibility Study: A Safety Evaluation of the Gala Airway Treatment System on Patients With Chronic Bronchitis

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

Detailed Summary:

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.


Sponsor: Gala Therapeutics, Inc.

Current Primary Outcome: Safety: Incidence and evaluation of any serious adverse events associated with the Gala Airway Treatment System through 6 months. [ Time Frame: 6 months ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical Utility - Histology [ Time Frame: 12 months following treatment session number 2 ]
    Histopathological evidence of change in mucus producing cells within the airway.
  • Clinical Utility - Pulmonary Function [ Time Frame: Pulmonary function testing measured at 1week, 3 months, 6 months and 12 months post treatment number 2 ]
    Pulmonary function testing utilizing the FEV1 and FVC tests
  • Quality of Life [ Time Frame: Quality of Life Indices will be completed at 1 week post treatment 1, at treatment 2, and 1 week, 3 months, 6 months and 12 months post treatment 2 ]
    Patient filled respiratory questionnaire
  • 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)


Original Secondary Outcome: Same as current

Information By: Gala Therapeutics, Inc.

Dates:
Date Received: March 30, 2017
Date Started: January 20, 2017
Date Completion: June 30, 2019
Last Updated: April 4, 2017
Last Verified: April 2017