Emphysematous Lung Sealant Therapy in Homogeneous Emphysema
Recruitment status was: Not yet recruiting
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Post Market Investigator Sponsored Study of Emphysematous Lung Sealant Therapy in Homogeneous Emphysema Using a Modified Treatment Strategy|
- Overall safety assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Overall assessment of safety based on review
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.
Changes from baseline in clinical pathology or lung physiology based on:
- Blood gases
- Pulmonary function data
- Radiology data
- Efficacy Evaluations will include: [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- CT evidence of lobar volume reduction at site(s) of AeriSeal administration at 12 weeks assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm.
- Change from baseline at 12 and 24 weeks in RV/TLC
- Change from baseline at 12 and 24 weeks in FEV1
- Change from baseline at 12 and 24 weeks in FVC
- Change from baseline at 12 and 24 weeks in 6 MWT
- Change from baseline at 12 and 24 weeks in MRCD score
- Change from baseline at 12 and 24 weeks in SGRQ total domain score
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: ELVR Procedure
A single subsegmental AeriSeal System treatment consists of the administration of 10 mL Foam Sealant administered through a standard fiberoptic bronchoscope via an administration syringe and bronchoscopic catheter into the target area of damaged lung
Procedure: ELVR Procedure
Lung Volume Reduction Procedure
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728662
|Rabin Medical Center|
|Petach Tikva, Israel, 49100|
|Principal Investigator:||Mordechai R Kramer, MD||Rabin Medical Center|