A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Safety - Incidence of respiratory serious adverse events (SAEs)
研究概览
简要总结
The Pulmair Implantable Artificial Bronchus (IAB) is a device intended for implantation into the diseased bronchi of emphysema patients. The IAB is indicated for bronchoscopic treatment of adults with Chronic Obstructive Pulmonary Disease (COPD)/emphysema to relieve hyperinflation and allow bidirectional ventilation of the affected lobes.
The objective of this trial is to demonstrate a suitable benefit/risk profile to support a subsequent trial of the safety and effectiveness of the IAB to achieve its intended purpose.
The trial will enroll 24 subjects implanted with IAB(s), at no more than three study centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Diagnosis of COPD/emphysema
- •Age 40 to 75 years
- •Body Mass Index (BMI) less than 30 kg/m2
- •6-minute walk Distance between 100 meters and 500 meters at baseline exam
- •Stable disease with less than 10 mg prednisone (or equivalent) daily
- •Non-smoking for 4 months prior to screening interview
- •FEV1 between 15% and 50% of predicted value at baseline exam
- •FEV1/Forced Vital Capacity (FVC) < 70%
- •mMRC score ≥ 2
排除标准
- •Currently participating in another clinical study
- •Women of child-bearing potential
- •More than 2 COPD exacerbation episodes requiring hospitalization in the last year at screening
- •Any COPD exacerbations within 6 weeks of planned intervention
- •Two or more instances of pneumonia episodes in the last year at screening
- •Clinically significant mucus production or chronic bronchitis
- •Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6 months of screening
- •Prior lung transplant, Lung Volume Reduction Surgery (LVRS), bullectomy or lobectomy
- •Clinically significant bronchiectasis
- •Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7 days
- •Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure > 45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram (completed within the last 3 months prior to screening visit)
- •Suspected pulmonary nodule or lung cancer
- •High Resolution Computed Tomography (HRCT) collected per CT scanning protocol within the last 6 months of screening date and evaluated by clinical site personnel using 3D segmentation software shows:
- •Large bullae encompassing greater than 30% of either lung
- •Insufficient landmarks to evaluate the CT study using the software as it is intended
- •All lobes are less than 25% parenchyma diseased (< -950 HU)
- •Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant
- •Total Lung Capacity (TLC) < 100% predicted at screening
- •Diffusing Capacity of Carbon Monoxide (DLCO) < 15% or > 50% of predicted value at screening
- •Partial pressure of carbon dioxide (PaCO2) > 50 mm Hg or Denver scale greater than 55 mm Hg on room air at screening
- •Partial pressure of oxygen (PaO2) < 45 mm Hg or Denver scale less than 30 mm Hg on room air at screening
- •Plasma cotinine level > 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) > 2.5% at screening
- •Any other conditions, which, in the opinion of the Investigator, would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study
研究组 & 干预措施
IAB System
Patients will be treated with IAB(s)
干预措施: IAB System (Device)
结局指标
主要结局
Safety - Incidence of respiratory serious adverse events (SAEs)
时间窗: From baseline to 90 days post implant (for endpoint evaluation)
The primary endpoint is the occurrence of respiratory SAEs: * Acute asthma/bronchospasm requiring intensive/critical care unit admission * Acute COPD exacerbation (is acute onset, life-threatening, requires hospitalization) * Airway injury from IAB placement/migration/airway stenosis requiring surgical intervention * Death from procedure/IAB * Massive hemoptysis (est. \>100 ml in 24hr requiring transfusion, surgery, or arterial embolization) from procedure/IAB * Pneumonia in treated lobe requiring hospitaliz., IV antibiotics, IAB removal * Pneumonia NOT in treated lobe (is life-threatening, acute onset, requires hospitaliz. \& IV antibiotics) * Pneumothorax requiring surgery * Tension pneumothorax (is life-threatening, acute onset, requires hospitaliz. \& treatment) * Respiratory failure requiring mechanical ventilatory support \>24hr A thoracic SAE composite, based on number of subjects experiencing a thoracic SAE, will also be calculated and tabulated.
次要结局
- Efficacy - European Quality of Life, 5-Dimensional Test (EQ-5D) Summary Index, absolute change(From baseline to 90 days post implant (for endpoint evaluation))
- Efficacy - Modified Medical Research Council (mMRC) dyspnea score, absolute change(From baseline to 90 days post implant (for endpoint evaluation))
- Efficacy - European Quality of Life, 5-Dimensional Test (EQ-5D) Summary Index, percent change(From baseline to 90 days post implant (for endpoint evaluation))
- Safety - Incidence of other serious adverse device effects (SADEs)(From baseline to 90 days post implant (for endpoint evaluation))
- Efficacy - Residual Volume (RV), absolute change(From baseline to 90 days post implant (for endpoint evaluation))
- Efficacy - Residual Volume (RV), percent change(From baseline to 90 days post implant (for endpoint evaluation))
- Efficacy - Six-Minute Walk Distance (6MWD), absolute change(From baseline to 90 days post implant (for endpoint evaluation))
- Efficacy - Forced Expiratory Volume in one second (FEV1), absolute change(From baseline to 90 days post implant (for endpoint evaluation))
- Efficacy - Forced Expiratory Volume in one second (FEV1), percentage change(From baseline to 90 days post implant (for endpoint evaluation))
- Efficacy - St. George's Respiratory Questionnaire (SGRQ) total score, absolute change(From baseline to 90 days post implant (for endpoint evaluation))
- Efficacy - St. George's Respiratory Questionnaire (SGRQ), percent change(From baseline to 90 days post implant (for endpoint evaluation))
- Efficacy - COPD Assessment Test (CAT) Total Score, percent change(From baseline to 90 days post implant (for endpoint evaluation))
- Efficacy - Six-Minute Walk Distance (6MWD), percent change(From baseline to 90 days post implant (for endpoint evaluation))
- Efficacy - COPD Assessment Test (CAT), absolute change(From baseline to 90 days post implant (for endpoint evaluation))