NCT07086339招募中不适用
A Two Center Trial of the Implantable Artificial Bronchus 50 Flex (IAB 50 Flex) in Patients With Severe Emphysema
Pulmair Medical, Inc.2 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2026年2月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence of serious adverse events
研究概览
简要总结
A Study at Two Hospitals Testing the Safety and Effectiveness of the IAB 50 Flex, a New Implant for Adults with Severe COPD or Emphysema
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
- 22 Years 至 —（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
- •At least 22-years of age
- •18 ≤ BMI ≤ 32
- •6-minute walk Distance of between 100 - and 400 meters
- •Stable disease with less than 10-mg prednisone (or equivalent) daily
- •Non-smoking for 4-months prior to screening interview (this includes tobacco, vaping, marijuana, etc.).
- •FEV1 between 15% and 45% of predicted value at baseline exam
- •FEV1/FVC <70%
- •Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation less than -950 HU, as determined by CT core lab.
- •Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score less than -950 HU, as determined by CT core lab.
- •RV > 175% of predicted value.
- •mMRC score ≥ 2
排除标准
- •Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment
- •α-1 Antitrypsin deficiency
- •Women of child-bearing potential
- •More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening
- •Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention
- •Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening
- •Clinically significant mucus production or chronic bronchitis
- •Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6-months of screening
- •Prior lung transplant, LVRS, bullectomy, lobectomy or endoscopic lung volume reduction (ELVR)
- •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
- •Suspected malignant pulmonary nodule or other lung cancer
- •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
- •TLC < 100% predicted at screening
- •DLCO < 15% or > 50% of predicted value at screening
- •PaCO2 > 50 mm Hg at screening
- •PaO2 < 45 mm Hg in room air at screening
- •Plasma cotinine level > 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) >2.5% at screening.
- •Current diagnosis of substance abuse disorder.
- •Current diagnosis of any of the following: Major Depressive Disorder (MDD), Schizoaffective Disorder, Schizophrenia, Borderline Personality Disorder, Bipolar Disorder
- •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
Treatment group
Experimental
One or two procedures involving placement of up to 10 IAB implants in one or both lungs
干预措施: Implantable pulmonary stent (Device)
结局指标
主要结局
Incidence of serious adverse events
时间窗: Ninety (90) days from the last IAB implanted.
The incidence of respiratory serious adverse events related to the device or procedure (SADEs) through the 90-day endpoint.
次要结局
未报告次要终点
研究者
研究点 (2)
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