Table 3.

Exclusion Criteria

1	BMI between < 18 or > 35.
2	Has an implantable electronic device.
3	Uncontrolled diabetes as evidenced by an HbA1c > 7%.
4	Pulmonary nodule thought to be at high risk of malignancy.
5	Malignancy treated with radiation or chemotherapy within 2 years of consent.
6	More than 3 respiratory-related hospitalizations within 1 year of consent.
7	Asthma as defined by the current GINA guidelines.
8	Patient has been previously diagnosed with a non-COPD lung disease or has a documented medical history of pneumothorax.
9	Clinically relevant bronchiectasis, defined as severe single lobe or multilobar bronchial wall thickening associated with airway dilation on CT scan leading to cough and tenacious sputum on most days.
10	Pre-existing diagnosis of pulmonary hypertension, defined as a sustained elevation of the systolic pulmonary artery pressure ≥ 25 mmHg at rest by right heart catheterization or estimated by echocardiogram to be > 40 mmHg.
11	Myocardial infarction within last 6 months, EKG with evidence of life-threatening arrhythmias or acute ischemia, pre-existing documented evidence of a LVEF < 45%, stage C or D (ACC/AHA) or Class III or IV (NYHA) congestive heart failure, or any other cardiac findings that make the participant an unacceptable candidate for a bronchoscopic procedure utilizing general anesthesia.
12	Known gastrointestinal motility disorder or previous abdominal surgical procedure on stomach, esophagus, or pancreas.
13	A GCSI total symptom score ≥ 18.0 (sum of PAGI-SYM questions 1–9) prior to treatment.
14	Any disease or condition that might interfere with completion of a procedure or this study (e.g., structural esophageal disorder, life expectancy < 3 years).
15	Prior lung or chest procedure. Segmentectomy for benign lesion or segmentectomy for non-recurrent cancer ≥2 years is allowed.
16	Daily use of > 10 mg of prednisone or its equivalent at the time of consent.
17	Recent (within 3 months of consent) opioid use.
18	Known contraindication or allergy to medications required for bronchoscopy or general anesthesia that cannot be medically controlled.
19	Screening chest CT scan reveals bronchi anatomy cannot be fully treated with available catheter sizes, presence of severe emphysema > 50%, lobar attenuation area or severe bullous disease (> 1/3 hemithorax) (as determined by the CT core lab using a single density mask threshold of − 950 HU) or site discovery of a mass that requires treatment.
20	In the opinion of the treating Investigator, use of the Nuvaira System is not technically feasible due to patient anatomy or other clinical finding.
21	Enrolled in another clinical trial that has not completed follow-up.

Abbreviations: ACC/AHA American College of Cardiology/American Heart Association; BMI body mass index; GCSI gastroparesis cardinal symptom index; GINA Global Initiative for Asthma; LVEF left ventricular ejection fraction; NYHA New York Heart Association; PAGI-SYM patient assessment of gastrointestinal disorders symptom severity index