Lung Diseases Clinical Trial
Official title:
A Continuation Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema
Verified date | November 2013 |
Source | Aeris Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of HealthIsrael: Ethics Commission |
Study type | Interventional |
The purpose of this study is to assess the long term safety and efficacy of AeriSeal System treatment administered at up to 4 subsegments during a single treatment session for lung volume reduction in patients with advanced emphysema through 48 weeks after treatment.
Status | Terminated |
Enrollment | 18 |
Est. completion date | November 2013 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Patients must have been enrolled in the 03-C10-002PLV Aeris' Investigational Study and completed a minimum of 12 weeks of follow-up following AeriSeal System treatment. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | The Soroka Medical Center | Beer Sheva | |
Israel | The Rabin Medical Center | Petach Tikva |
Lead Sponsor | Collaborator |
---|---|
Aeris Therapeutics |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in Percent Volume of Lung | Computed Tomography (CT) evidence of lobar volume reduction at site(s) of AeriSeal Foam Sealant administration at 48 weeks post treatment, assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm. | 48 Weeks following treatment | No |
Secondary | Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC) | Change from baseline at 24 and 48 weeks in RV/TLC | 24 and 48 weeks following treatment | No |
Secondary | Change in Forced Expiratory Volume in 1 Second (FEV1) | Change from baseline at 24 and 48 weeks in FEV1 | 24 and 48 weeks following treatment | No |
Secondary | Change in Forced Vital Capacity (FVC) | Change from baseline at 24 and 48 weeks in FVC | 24 and 48 weeks following treatment | No |
Secondary | Change in distance walked in six minutes | Change from baseline at 24 and 48 weeks in 6 Minutes Walk Test (6MWT) | 24 and 48 weeks following treatment | No |
Secondary | Change in Medical Research Council Dyspnea (MRCD) score | Change from baseline at 24 and 48 weeks in MRCD score | 24 and 48 weeks following treatment | No |
Secondary | Change in St. George's Respiratory Questionnaire (SGRQ)domain score | Change from baseline at 24 and 48 weeks in SGRQ total domain score | 24 and 48 weeks following treatment | No |
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