Prospective, multicenter, single-arm (non-randomized) study of Targeted Lung Denervation (TLD) Therapy in subjects with severe asthma.
Prospective, multicenter, single-arm (non-randomized) study. All patients will undergo a run in period on optimal medical therapy as part of eligibility testing. Final determination to initiate treatment will be made after initial airway inspection. A total of 20 patients will be treated. Inflammatory biomarkers (washes and brushes) will be collected in all patients and bronchial biopsies will be collected from the last 10 patients at the time of treatment and at 90-days post-treatment. All patients will be prescribed peri-procedural antibiotics and steroids to minimize procedural risks. All patients will be provided a mobile handheld spirometer to measure and record daily peak expiratory flow both before and after treatment to monitor lung function. Patient follow-up will be conducted out to 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
The Nuvaira Lung Denervation System, manufactured by Nuvaira, Inc., is intended to deliver TLD Therapy using predetermined radiofrequency (RF) energy over a predetermined period of time to ablate airway nerve trunks which are located on the outside of the main bronchi.
CHU de Grenoble
Grenoble, France
Thoraxklinik Heidelberg
Heidelberg, Germany
Academic Medical Center
Amsterdam, Netherlands
Universtity Medical Center Groningen
Groningen, Netherlands
Freedom from device related therapeutic interventions
Number and % of patients free from device related therapeutic interventions will be reported. Therapeutic intervention is defined as administration of non-protocol required antibiotics or steroids, an endoscopic procedure or surgery to treat findings and/or conduction of another diagnostic test to assess the treatment area due to safety concerns.
Time frame: 7 days, 1 month, 3 months, 6 months, and 12 months post-procedure
Device Success
Number and % of subjects with reported Device Success, defined as the ability to insert and place the dNerva Catheter to its intended locations and intact removal.
Time frame: 1 day
Technical Success
Number and % of subjects with reported Technical Success, defined as device success with the ability to deliver RF energy to each intended location as confirmed by the Nuvaira Console.
Time frame: 1 day
Change in Quality of Life (QOL)
Changes in the Asthma Quality of Life Questionnaire (AQLQ) over time will be assessed. Comparisons will be made to baseline score.
Time frame: Through study completion, an average of 3 years
Change in Asthma Control
Changes in the Asthma Control Questionnaire (ACQ) over time will be assessed. Comparisons will be made to baseline score.
Time frame: Through study completion, an average of 3 years
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Queen Elizabeth University Hospital
Glasgow, Scotland, United Kingdom
Chelsea & Westminster Hospital NHS Foundation Trust
London, United Kingdom
Royal Brompton & Harefield NHS Foundation Trust
London, United Kingdom
NUH Nottingham City Hospital
Nottingham, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom