Emphysematous Lung Sealant Therapy in Homogeneous Emphysema

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01728662
First received: October 23, 2012
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Patients With Advanced Homogeneous Emphysema
Procedure: ELVR Procedure

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Overall safety assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 8
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)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have a diagnosis of GOLD Stage III/IV homogeneous emphysema
  2. FEV1/FVC <70 % predicted, FEV1 of < 50% predicted, TLC > 100% of predicted, and RV > 150% predicted.
  3. chest CT scan showing evidence of tissue destruction indicative of homogeneous (uniformly distributed) emphysema.
  4. Patients must also have ≤ 15% perfusion in both upper lobes on a quantitative lung perfusion scan indicating bilateral target sites for therapy.
  5. Patients must be > 40 years of age.

Exclusion Criteria:

  1. Alpha-1 antitrypsin deficient patients (i.e. those with serum levels < 80 mg/dL, or < 11 µmol/L or 57 mg/dL).
  2. patients who are pregnant or breast feeding.
  3. patients who are smoking.
  4. patients using other investigational medications will be excluded.
  5. 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.
  6. have no significant co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.
  7. Specifically, patients should not have a history of prior major thoracic surgery, HIV infection, clinically significant asthma, bronchiectasis, pulmonary hypertension or coronary heart disease.
  8. Patients must also not be dependent on medications that could increase the risk of undergoing treatment or adversely effect the chance of recovering from treatment (i.e. high dose steroids, immunosuppressive agents, or anticoagulants)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01728662

Contacts
Contact: Mordechai R Kramer, MD kremerm@clalit.org.il

Locations
Israel
Rabin Medical Center Recruiting
Petach Tikva, Israel, 49100
Contact: Mordechai R Kramer, MD         
Principal Investigator: Mordechai R Kramer, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Mordechai R Kramer, MD Rabin Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01728662     History of Changes
Other Study ID Numbers: RMC127000 CTIL
Study First Received: October 23, 2012
Last Updated: November 13, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
emphysema
lung volume reduction therapy

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014