Patients With Advanced Homogeneous Emphysema Clinical Trial
Official title:
Post Market Investigator Sponsored Study of Emphysematous Lung Sealant Therapy in Homogeneous Emphysema Using a Modified Treatment Strategy
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment