NL-OMON55508招募中不适用
A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the Nuvaira* Lung Denervation System in Subjects with Chronic Obstructive Pulmonary Disease (COPD) - AIRFLOW 3
VAIRA inc.0 个研究点目标入组 65 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) Subject >=40 years of age at the time of consent;
- •2) Women of child bearing potential must not be pregnant, evidenced by a
- •negative pregnancy test (blood or urine) pre-treatment, or lactating and agree
- •not to become pregnant for the duration of the study;
- •3) Smoking history of at least 10 pack years;
- •4) Not smoking or using any other inhaled substance (e.g., cigarettes, vaping,
- •cannabis, pipes) for a minimum of 2 months prior to consent and agrees to not
- •start for the duration of the study;
- •5)Subject has received a flu vaccination within the 12 months prior to the
- •procedure or agrees to obtain vaccination once it becomes available and agrees
- •to annual vaccinations for the duration of the study;
- •6) SpO2 >=89% on room air at the time of screening;
- •7) CAT score >=10 at the time of screening;
- •8) Diagnosis of COPD with 25% <= FEV1 <=80% of predicted, PaCO2 < 50 (if FEV1
- •<30%) and FEV1/FVC <70% (post-bronchodilator);
- •9) Documented history of >= 2 moderate COPD exacerbations or >= 1 severe COPD
- •exacerbation leading to hospitalization in the 12 months prior to consent with
- •at least one exacerbation occurring
- •while the subject was on optimal medical care (taking a LAMA and a LABA, or
- •scheduled SABA or SAMA instead of either a LAMA or a LABA, not both, as regular
- •respiratory maintenance
- •medication);
- •10)Subject is on optimal medical care at the time of consent;
- •11) If subject has participated in a formal pulmonary rehabilitation program
- •recently, program completion must have occurred >=3 months prior to consent; if
- •in a maintenance program, subject agrees to continue their current program
- •through their 12-month follow-up visit;
- •NOTE: Prior participation in a pulmonary rehabilitation program is not required
- •for inclusion in the study.
- •12) Subject is a candidate for bronchoscopy in the opinion of the physician
- •investigator or per hospital guidelines and is able to discontinue blood
- •thinning medication peri-procedurally;
- •13) The subject is able and agrees to complete all protocol required baseline
- •and follow up tests and assessments including taking certain medications (e.g.,
- •azithromycin, prednisolone / prednisone);
- •14) Subject has provided written informed consent using a form that has been
- •reviewed and approved by the Institutional Review Board (IRB) / Ethics
- •Committee (EC).
排除标准
- •1) Body Mass Index <18 or >35;
- •2) Subject has an implantable electronic device and has not received
- •appropriate medical clearance;;
- •3) Uncontrolled diabetes in the opinion of the investigator;
- •4) Malignancy treated with radiation or chemotherapy within 1 years of consent;
- •5) Asthma as defined by the current Global Initiative for Asthma (GINA)
- •guidelines;
- •6)Subject diagnosed with a dominant non-COPD lung disease or condition
- •affecting the lungs which is the main driver of the subjects clinical symptoms
- •(e.g., cystic fibrosis, paradoxical vocal cord motion, eosinophilic
- •granulomatosis with polyangiitis (EGPA), allergic bronchopulmonary
- •aspergillosis, interstitial lung disease or active tuberculosis) or has a
- •documented medical history of pneumothorax within 1 years of consent;
- •7) 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;
- •8) Pre-existing diagnosis of pulmonary hypertension, clinical evidence of
- •pulmonary hypertension,
- •(cardiovascular function impairment including peripheral edema) and mPAP >=25
- •mmHg at rest by right heart catheterization (or estimated right ventricular
- •systolic pressure >50 mmHg by
- •echocardiogram if no previous right heart catheterization)
- •9) Myocardial infarction within last 6 months, EKG with evidence of life
- •threatening arrhythmias or acute ischemia, pre-existing documented evidence of
- •a LVEF <40%, stage C or D (ACC/AHA) or Class III or IV (NYHA) congestive heart
- •failure, or any other past or present cardiac findings that make the subject an
- •unacceptable candidate for a bronchoscopic procedure utilizing general
- •anesthesia;
- •10) Surgical procedures(s) on the stomach, esophagus or pancreas performed <=2
- •years prior to consent or ongoing related symptoms within the past year;
- •11)Symptomatic gastric motility disorder(s) (e.g. gastroparesis) as evidenced
- •by GCSI score >=18.0, severe uncontrolled GERD (e.g., refractory heartburn,
- •endoscopic esophagitis) or severe dysphagia (e.g., esophageal stricture,
- •achalasia, esophageal spasm); NOTE: Subjects with a hiatal hernia are allowed
- •if subject meets all other enrollment criteria.
- •12) Any disease or condition that might interfere with completion of a
- •procedure or this study (e.g., structural esophageal disorder, life expectancy
- •<3 years);
- •13) Prior lung or chest procedure (e.g., lung transplant, LVRS, BLVR, lung
- •implant, metal stent, valves, median sternotomy, bullectomy, lobectomy,
- •segmentectomy or other interventional lung or chest procedure) performed <=1
- •year of consent);
- •14) Daily use of >10 mg of prednisone or its equivalent at the time of consent;
- •15) Chronic use of *40 mg MEDD opioid only medication per day;
- •16) Known contraindication or allergy to medications required for bronchoscopy
- •or general anesthesia (e.g., lidocaine, atropine, propofol, sevoflurane) that
- •cannot be medically controlled;
- •17) Baseline 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
- 另有 2 项未显示
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