NL-OMON50551招募中不适用
A multicenter, prospective trial of the Implantable Artificial Bronchus (IAB) in adults suffering from COPD/emphysema - IAB-1 study
Pulmair Medical, Inc.0 个研究点目标入组 10 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
- 10
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. Signed Informed Consent
- •2. Diagnosis of COPD/emphysema
- •3. Age 40 to 75 years
- •4. BMI less than 30 kg/m2
- •5. 6-minute walk Distance between 100 meters and 500 meters at baseline exam
- •6. Stable disease with less than 10 mg prednisone (or equivalent) daily
- •7. Non-smoking for 4 months prior to screening interview
- •8. FEV1 between 15% and 50% of predicted value at baseline exam
- •9. FEV1/FVC <70%
- •10. RV > 175%
- •11. mMRC score >= 2
排除标准
- •1. Currently participating in another clinical study
- •2. Women of child-bearing potential
- •3. More than 2 COPD exacerbation episodes requiring hospitalization in the last
- •year at screening
- •4. Any COPD exacerbations within 6 weeks of planned intervention
- •5. Two or more instances of pneumonia episodes in the last year at screening
- •6. Clinically significant mucus production or chronic bronchitis
- •7. Myocardial Infarction or unstable / uncontrolled congestive heart failure
- •within 6 months of screening
- •8. Prior lung transplant, LVRS, bullectomy or lobectomy
- •9. Clinically significant bronchiectasis
- •10. Unable to safely discontinue anti-coagulants or platelet activity
- •inhibitors for 7 days
- •11. 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)
- •12. Suspected pulmonary nodule or lung cancer
- •13. 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:
- •a. Large bullae encompassing greater than 30% of either lung
- •b. Insufficient landmarks to evaluate the CT study using the software as it is
- •c. All lobes are less than 25% parenchyma diseased (< -950 HU)
- •14. Any cardiac comorbidity which the PI believes would compromise the safety
- •of the patient after an IAB implant
- •15. TLC < 100% predicted at screening
- •16. DLCO < 15% or > 50% of predicted value at screening
- •17. PaCO2 > 50 mm Hg or Denver scale greater than 55 mm Hg on room air at
- •18. PaO2 < 45 mm Hg or Denver scale less than 30 mm Hg on room air at screening
- •19. Plasma cotinine level > 13.7 ng/ml or arterial carboxyhemoglobin >2.5% at
- •20. Any other conditions, which, in the opinion of the Investigator, would make
- •the patient unsuitable for inclusion, or could interfere
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