NL-OMON39727已完成3 期
ung Volume Reduction Coil for Treatment in Patients with Emphysema (RENEW) Study - RENEW Study
PneumRx, Inc0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- •>=35 years of age.
- •CT scan indicates bilateral emphysema.
- •Subject has post-bronchodilator FEV1 <=45% predicted.
- •Subject has Total Lung Capacity >100% predicted.
- •Subject has residual volume (RV) >=225% predicted.
- •Subject has marked dyspnea scoring >=2 on mMRC scale of 0-4.
- •Subject has stopped smoking for at least 8 weeks prior to entering the study
- •Subject has completed a pulmonary rehabilitation program within 6 months prior to treatment and/or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 6 months prior to baseline testing.
排除标准
- •Subject has co-morbidities that may significantly reduce subject*s ability to improve exercise capacity (e.g. severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea.
- •Subject has a change in FEV1 >20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of > 200 mL) post-bronchodilator.
- •Subject has DLCO <20% of predicted.
- •Subject has severe gas exchange abnormalities as defined by: PaCO2 >55 mm Hg, PaO2 <45mm Hg on room air.
- •Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment.
- •Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >50 mm Hg via right heart catheterization and/or echocardiogram.
- •Subject has an inability to walk >140 meters.
- •Subject has evidence of other severe disease (such as, but not limited to, lung cancer or renal failure), which in the judgment of the investigator may compromise survival of the subject for the duration of the study.
- •Subject has clinically significant bronchiectasis.
- •Subject has giant bullae >1/3 lung volume.
- •Subject has had previous LVR surgery, lungtransplantation, lobectomy , LVR devices or other
- •devices to treat COPD in either lung.
- •Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
- •Subject is taking >20 mg prednisone (or equivalent dose of a similar steroid) daily.
- •Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.
- •Subject is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as heparin or Coumadin) which cannot be stopped for seven (7) days prior to procedure.
- •Subject has a sensitivity or allergy to Nickel
- •Subject has been diagnosed with alpha-1 antitrypsin
- •deficiency (AATD).
研究者
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