NL-OMON52333招募中不适用
Fissure Closure with the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients with Severe Emphysema; A Multicenter, Prospective Trial - CONVERT trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
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
- •Inclusion Criteria
- •1. Subject is willing and able to provide Informed Consent and to participate
- •in the study.
- •2. Subject is >= 40 and <= 75 years of age at the time Informed Consent signature.
- •3. Subject has at least one lobe with >= 50% emphysema destruction (at *910 HU)
- •as determined
- •4. Subject has a diagnosis of homogenous or heterogeneous emphysema, confirmed
- •scan. Heterogeneous emphysema defined as >= 15% difference (at -910 HU) in
- •destruction score of adjacent lobes by HRCT.
- •5. Subject has a gap in the interlobar fissure that corresponds to one or more
- •segments as
- •determined by QCT.
- •6. Subject has clinically significant dyspnea with a mMRC Dyspnea score >= 2.
- •7. Subject has a Six-Minute Walk Distance >= 250 meters.
- •8. Subject has post-bronchodilator FEV1 >= 15% predicted and <= 50% predicted.
- •9. Subject has post-bronchodilator Total Lung Capacity >= 100% predicted.
- •10. Subject has post-bronchodilator Residual Volume >= 150% predicted if
- •heterogeneous
- •emphysema and >= 200% predicted if homogeneous emphysema.
- •11. Subject has stopped smoking for at least eight (8) weeks prior to Screening
- •visit as confirmed
- •by carboxyhemoglobin or cotinine levels.
- •12. Subject has received preventive vaccinations against potential respiratory
- •consistent with local recommendations or policy.
排除标准
- •Exclusion Criteria
- •1. Subject has severe bullous emphysema where bulla is >= 1/3 of the total lung
- •2. Subject has had prior lung volume reduction surgery, prior lobectomy or
- •pneumonectomy,
- •prior lung transplantation, prior airway stent placement, prior ipsilateral
- •pleurodesis, or prior
- •endobronchial lung volume reduction therapy of any type.
- •3. Subject has evidence of active respiratory infection.
- •4. Subject has an ongoing COPD exacerbation or bronchospasm.
- •5. Subject has a known allergy to the device components:
- •a. Polyether block amide - PEBAX®
- •b. Polyvinyl Alcohol
- •c. Glutaraldehyde
- •d. Nitinol (nickel-titanium) or its constituent metals (nickel or titanium)
- •e. Silicone
- •6. Subject requires ventilatory support (invasive or non-invasive).
- •7. Subject has post-bronchodilator Diffusion Capacity (DLCO) < 20% predicted.
- •8. Subject cannot tolerate corticosteroids or relevant antibiotics.
- •9. Subject has other relevant comorbidities as judged by the Investigator or is
- •deconditioned
- •and cannot tolerate the stress of post-treatment inflammatory response.
- •10. Subject has had three (3) or more COPD exacerbations requiring
- •hospitalization during the
- •year prior to Informed Consent signature.
- •11. Subject has severe gas exchange abnormalities as defined by any one of the
- •following (test
- •conducted at rest on room air as tolerated, or on up to 4 L/min supplemental O2)
- •a. PaCO2 >= 55 mm Hg (7.3 kPa)
- •b. PaO2 < 45 mm Hg (6.0 kPa)
- •c. SpO2 < 90%
- •12. Subject has uncontrolled pulmonary hypertension, defined as peak pulmonary
- •pressure > 45 mm Hg on echocardiogram or right heart catheterization.
- •13. Subject use of systemic steroids > 20 mg/day prednisolone or equivalent
- •within 4 weeks of
- •Informed Consent signature.
- •14. Subject use of immunosuppressive agents within four (4) weeks of Informed
- •15. Subject whose use heparins and oral anticoagulants (e.g., warfarin,
- •dicumarol) cannot be
- •discontinued according to local pre-procedural protocols. Note: antiplatelet
- •drugs including
- •aspirin and clopidogrel are permitted.
- •16. Subject*s CT scan indicates the presence of any the following radiologic
- •abnormalities:
- •a. Pulmonary nodule on CT scan greater than 0.8 cm in diameter (Does not apply
- •present for one (1) year or more without increase in size or if proven benign by
- •b. Radiologic picture consistent with active pulmonary infection, e.g.,
- •unexplained
- •parenchymal infiltrate.
- •c. Significant interstitial lung disease.
- •d. Significant pleural disease.
- 另有 16 项未显示
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