An interventional study of ELVR Procedure in Patients With Advanced Homogeneous Emphysema, sponsored by Rabin Medical Center. Status unknown at 1 site in Israel. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-11-20.
Sponsored by Rabin Medical Center · Not applicable, Interventional, and Treatment
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.
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.
187 studies on the registry are indexed under Pulmonary Emphysema; 19 are open to participants now.
This study's planned enrollment of 8 is below the median of 33 across 128 interventional studies indexed under Pulmonary Emphysema.
Browse Pulmonary Emphysema studies →Rabin Medical Center is the lead sponsor of 385 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
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
Overall safety assessment
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
Time frame: 6 months
Efficacy Evaluations will include:
* 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
Time frame: 6 months
This study is status unknown, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Rabin Medical Center