PULmonary Stimulation for Asthma Relief

A vizsgálat adatai

Ki végzi

Spiro Medical, Inc.

Azonosító

NCT07709754

A regiszteradat frissítve

2026. október 13.

Eredeti leírás

This study aims to assess the safety and efficacy of Pulmonary Neuromodulation in patients suffering from moderate to severe asthmaA teljes eredeti leírásKevesebb

Randomized, Controlled, Multi-Center, Delayed Activation Feasibility Clinical Study to Evaluate the Safety and Efficacy of Pulmonary NeuroModulation (PNM) for the Treatment of Subjects With Moderate to Severe Uncontrolled Asthma - PULSAR: Pulmonary Stimulation for Asthma Relief

This study aims to assess the safety and efficacy of Pulmonary Neuromodulation in patients suffering from moderate to severe asthma

Bevonási feltételek: Subject has a diagnosis of uncontrolled moderate to severe asthma, diagnosed by an Allergist or Pulmonologist, for a minimum of 1 year prior to randomization. "Uncontrolled" status defined by poor symptom control, despite optimized treatment with high-dose ICS-LABA and/or biologics who have a baseline ACT score less than or equal to 15; Subjects previously or currently on biologics for at least 6 months (Omalizumab, Mepolizumab, Reslizumab, Benralizumab, Dupilumab, Tezepelumab) that are uncontrolled and meet all inclusion and exclusion criteria; 18 to 75 years of age; Subjects have a baseline AQLQ of less than 2.5; Subject is a surgical candidate with no contraindications for PNM implantation.

Kizáró feltételek: Requires continuous anticoagulant medications or taking alternative anticoagulant drugs or supplements within 10 days of implantation; In the 6 weeks prior to enrollment the subject has had a lower respiratory tract infection or asthma exacerbation that required: antibiotics, or systemic corticosteroids; Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints (e.g. Crohn's disease, moderate to severe fibromyalgia, chronic pain, etc.) or a medical condition that requires the subject to be treated with systemic opioids other than for post-surgical pain; Planning to have diathermy, surgery requiring electrocautery, or high output ultrasonic exposure during the course of the study; Any other implanted devices (e.g., drug delivery pumps, pacemaker, ICD) including neurostimulators whether turned on or off. Passive implants (e.g., prostheses) are allowed, but no implanted metal should be at the Neurostimulator implant site, both the IPG or lead; Other chronic lung diseases including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), chronic bronchitis, vocal cord dysfunction, eosinophilic granulomatosis with polyangiitis (EGPA), history of lung cancer, or interstitial lung disease, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways; History of recurrent surgical infections (e.g. MRSA); Patients prescribed systemic corticosteroids for any condition, other than asthma, in the last 6 weeks. Subjects with asthma on oral corticosteroids taking more than 15mg/day; History of thoracic spine surgery and or spinal abnormalities, i.e., no more than 5 lumbar vertebrae, no scoliosis, or spinal deformities; Any neurological condition that could interfere with normal lung function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia); Uncontrolled diabetes (A1C > 8%, documented in the last three (3) months) or other medical condition determined by the Investigator that should be excluded; Documented history of allergic response to titanium, platinum, polyurethane, epoxy, or silicone; Significant coronary artery occlusive disease, angina, history of myocardial infarction and/or coronary artery stent(s), congestive heart failure, or uncontrolled cardiac arrythmias, cardiac stress test within the last 6 months with an Ejection Fraction of less than 45%; Current smokers or subjects with a significant smoking history (e.g., >10 pack years for subjects less than 40 years of age and >15 pack years for subjects 40 years and older) who have smoked within the last 6 months; BMI> 35; A female with a positive urine pregnancy test or not using adequate contraception; Currently participating in another treatment clinical trial; Subject lacks capacity to consent for themselves.

ClinicalTrials.gov NCT07709754