A Dose Ranging Study of the Aeris Polymeric Lung Volume Reduction (PLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema

Study Overview
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Brief Summary
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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.

Conditions
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Advanced Emphysema

Intervention / Treatment
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* Device: Polymeric Lung Volume Reduction System (PLVR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PLVR<br> | Device: Polymeric Lung Volume Reduction System (PLVR)<br>* 20ml (each) of polymer will be injected into 2, 3 or 4 subsegments during the first treatment. Eligible patients may have 20ml (each) of polymer will be injected into 2 or 3 subsegments during the second treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC) | Change from baseline in RV/TLC ratio at 12 and 24 weeks following treatment | 12 and 24 weeks following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Forced Expiratory Volume in 1 Second (FEV1) | o Change from baseline in FEV1 (post bronchodilator) at 12 and 24 weeks following treatment | 12 and 24 weeks following treatment | 
| Change in Forced Vital Capacity (FVC) | Change from baseline in FVC (post bronchodilator) at 12 and 24 weeks following treatment | 12 and 24 weeks following treatment | 
| Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLco) | Change from baseline in DLco at 12 and 24 weeks following treatment | 12 and 24 weeks following treatment | 
| Change in Medical Research Council Dyspnea (MRCD) score | Change from baseline in MRCD score at 12 and 24 weeks | 12 and 24 weeks following treatment | 
| Change in distance walked in six minutes | Change from baseline at 12 and 248 weeks in 6 Minutes Walk Test (6MWT) | 12 and 24 weeks following treatment | 
| Change in St. George's Respiratory Questionnaire (SGRQ) domain score | Change from baseline in disease-specific health related quality of life assessment (SGRQ) at 12 and 24 weeks following treatment | 12 and 24 weeks following treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emphysema, aeris, PLVR, BLVR, germany, treatment, device, breathing