A Study of the Gala Airway Treatment System for the Treatment of Chronic Bronchitis in the United States

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Jacksonville, Florida: 18-008674
    NCT ID: NCT03631472
    Sponsor Protocol Number: CS003

About this study

The purpose of this study is to assess the safety and clinical utility of the Gala Airway Treatment System on patients with chronic bronchitis in the United States.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • 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.
  • 2. Subject has 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.
  • 3. Subject has had 1 or more COPD exacerbations, defined as an acute worsening in respiratory symptoms that requires additional treatment, in the 12-months prior to enrollment.
  • 4. Subject has a cigarette smoking history of at least ten packs years.
  • 5. Subject in the opinion of the site investigator can undertake the processes and procedures of the clinical trial and has provided a signed informed consent.

Exclusion Criteria:

  • Subject has lower respiratory infection (e.g., common cold, pneumonia, MAI, tuberculosis) within the six weeks prior to the initial treatment bronchoscopy or mild or moderate COPD exacerbation (per GOLD guidelines) within 4 weeks of the procedure.
  • 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 history of unresolved lung cancer in last 5 years.
  • Subject has bullous disease as defined by bullae exceeding 3 cm in diameter on HRCT.
  • Subject has pulmonary nodule or cavity rthat in the judgement of the investigator may require intervention during the course of the study.
  • 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 clinically significant cardiomyopathy.
  • Subject has severe bronchiectasis as outlined in the report of the CT scan of the chest by the interpreting radiologist or in the view of the PI, those findings bronchiectasis or any other significant second lung disease, are the main drivers of the patient's clinical symptoms.
  • Subject actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
  • Subject has the inability to walk over 100 meters in 6 minutes.
  • Subject has clinically significant serious medical conditions, such as: congestive heart failure, angina or myocardial infarction in the past year, renal failure, liver disease cerebrovascular accident within the past 6 months, uncontrolled diabetes, uncontrolled hypertension or autoimmune disease.
  • Subject has uncontrolled GERD.
  • Subject has sever pulmonary hypertension.
  • Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines).
  • Subject is pregnant, nursing, or planning to get pregnant during study duration.
  • Subject has received chemotherapy within the past 6 months or is expected to receive chemotherapy during participation in this study.
  • Subject is or has been in another clinical investigational study within 6 weeks of baseline.
  • Subject on anticoagulation for cardiovascular indications and is unable to have anticoagulants (i.e., Aspirin, Plavix, Coumadin) withheld for at least seven days prior to bronchoscopy in the opinion of the Investigator.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Sebastian Fernandez-Bussy, M.D.

Open for enrollment

Contact information:

Judy Olmos R.N., C.C.R.C.

(904)953-7898

Olmos.Judy@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available