A Dose Ranging Study of the Aeris Polymeric Lung Volume Reduction (PLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)
研究概览
简要总结
This is a multi-center, open-label, non-controlled Pilot Study. Approximately 24 patients will be assigned to one of 3 treatment groups (8 patients each group). Patients in each group will receive 2, 4, and 6 (3 followed by a retreatment of 3) subsegmental treatments, respectively. All patients will receive treatment in a single lung under conscious sedation or general anesthesia. Patients will be followed for 24 weeks after completion of PLVR treatment(s). Upon completion of 12-week follow-up, all safety and efficacy data will be analyzed to determine an effective treatment dose. Thereafter, Group 1 patients may elect to be retreated at additional sites so that their total dose received is consistent with the effective dose. All study patients will receive standard medical therapy in addition to PLVR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a diagnosis of advanced upper lobe predominant (ULP) emphysema or advanced disease in the superior lower lobes as defined by FEV1/FVC <70 % predicted, FEV1 of < 50% predicted, TLC > 100% of predicted, and RV > 135% predicted.
- •Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS.
- •Patients must be > 40 years of age, have symptoms despite medical therapy, and have none of the pre-specified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.
排除标准
- 未提供
结局指标
主要结局
Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)
时间窗: 12 and 24 weeks following treatment
Change from baseline in RV/TLC ratio at 12 and 24 weeks following treatment
次要结局
- Change in Forced Expiratory Volume in 1 Second (FEV1)(12 and 24 weeks following treatment)
- Change in Forced Vital Capacity (FVC)(12 and 24 weeks following treatment)
- Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLco)(12 and 24 weeks following treatment)
- Change in Medical Research Council Dyspnea (MRCD) score(12 and 24 weeks following treatment)
- Change in distance walked in six minutes(12 and 24 weeks following treatment)
- Change in St. George's Respiratory Questionnaire (SGRQ) domain score(12 and 24 weeks following treatment)