Post Market Investigator Sponsored Study of Emphysematous Lung Sealant Therapy in Homogeneous Emphysema Using a Modified Treatment Strategy
试验速览
- 阶段
- 不适用
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Overall safety assessment
研究概览
简要总结
This study will test that hypothesis that endoscopic lung volume reduction therapy performed using emphysematous lung sealant treatment can be improved using smaller doses delivered to more a larger number of treatment sites.
详细描述
This is an investigational, single arm, physician-sponsored study that will be conducted at Rabin Medical Center under the direction of Professor Mordechai Kramer. Patients will receive AeriSeal System therapy using a new treatment algorithm to deliver approved foam sealant components at doses at or below those previously shown to be safe and effective during prior studies. Investigational aspects of this study involve only the method of administration of material, not the material itself. The specific modifications to the treatment method proposed in this study include: 1) lowering the dose per subsegment of AeriSeal System Foam Sealant to 10 mL from the approved 20 mL dose; 2) administering the subsegmental doses at more anatomic locations with the goal of improving distribution of material and achieving more effective lung volume reduction; 3) eliminating the administration of air through the instrument channel of the bronchoscope following Foam Sealant delivery to simply and shorten the procedure, improving safety.
The study is designed to treat 8 patients. The first 4 patients will receive treatment with 10 mL of AeriSeal System Foam Sealant administered at 6 subsegments, 3 in each upper lobe (a dose of 60 mL of AeriSeal Foam Sealant). This group will be followed until all 4 have completed 1 month (28 day) follow-up. A safety review of the data will then be conducted prior to initiating treatment in the next group of 4 patients. This review will include an assessment of adverse events and physiological responses.
Assuming no emergent safety issues are identified, the next group of 4 patients will receive treatment with 10 mL of AeriSeal System Foam Sealant administered at 8 subsegments, 3 in each upper lobe, one in the upper-most portion of the right middle lobe, one in the upper-most portion of the lingual (a dose of 80 mL of AeriSeal Foam Sealant).
All patients will be followed for 24 weeks after completion of therapy and receive standard medical treatment in addition to treatment with the AeriSeal System.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a diagnosis of GOLD Stage III/IV homogeneous emphysema
- •FEV1/FVC <70 % predicted, FEV1 of < 50% predicted, TLC > 100% of predicted, and RV > 150% predicted.
- •chest CT scan showing evidence of tissue destruction indicative of homogeneous (uniformly distributed) emphysema.
- •Patients must also have ≤ 15% perfusion in both upper lobes on a quantitative lung perfusion scan indicating bilateral target sites for therapy.
- •Patients must be > 40 years of age.
排除标准
- •Alpha-1 antitrypsin deficient patients (i.e. those with serum levels < 80 mg/dL, or < 11 µmol/L or 57 mg/dL).
- •patients who are pregnant or breast feeding.
- •patients who are smoking.
- •patients using other investigational medications will be excluded.
- •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.
- •have no significant co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.
- •Specifically, patients should not have a history of prior major thoracic surgery, HIV infection, clinically significant asthma, bronchiectasis, pulmonary hypertension or coronary heart disease.
- •Patients must also not be dependent on medications that could increase the risk of undergoing treatment or adversely effect the chance of recovering from treatment (i.e. high dose steroids, immunosuppressive agents, or anticoagulants)
结局指标
主要结局
Overall safety assessment
时间窗: 6 months
Overall assessment of safety based on review 1. Clinical and laboratory results: * Serious Adverse Events (SAEs) * Serious Adverse Device Effects (SADEs) * Unanticipated Serious Adverse Device Effects (USADEs) * Physical Examinations * Vital signs * Serum chemistry and hematology. 2. Changes from baseline in clinical pathology or lung physiology based on: * Blood gases * Pulmonary function data * Radiology data
次要结局
- Efficacy Evaluations will include:(6 months)