Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 2 of 10 for:    pulmonx

Clinical Investigation of a Modified Staged Treatment Algorithm Using the AeriSeal System (STAGE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2016 by Pulmonx, Inc.
Sponsor:
Information provided by (Responsible Party):
Pulmonx, Inc.
ClinicalTrials.gov Identifier:
NCT02877459
First received: August 19, 2016
Last updated: August 24, 2016
Last verified: August 2016
  Purpose
A multicenter, prospective, single-arm clinical investigation to evaluate the short term and long term safety of a modified staged treatment algorithm using the AeriSeal System.

Condition Intervention
Emphysema
Device: AeriSeal System

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Single-Arm Clinical Investigation of a Modified Staged Treatment Algorithm Using the AeriSeal System - the AeriSeal-STAGE Trial

Resource links provided by NLM:


Further study details as provided by Pulmonx, Inc.:

Primary Outcome Measures:
  • Incidence of Serious Adverse Events [ Time Frame: 3‐months post treatment period ] [ Designated as safety issue: Yes ]
    Assessment of Serious Adverse Events (SAEs)


Secondary Outcome Measures:
  • Forced Expiratory Volume in one second (FEV1) [ Time Frame: Baseline, 3-months, 6-months and 12-months ] [ Designated as safety issue: Yes ]
    Percent mean change relative to baseline at 3-months, 6-months and 12-months for FEV1

  • Residual volume (RV) [ Time Frame: Baseline, 3-months, 6-months and 12-months ] [ Designated as safety issue: Yes ]
    Percent mean change relative to baseline at 3-months, 6-months and 12-months for RV

  • Exercise capacity as assessed by six‐minute walk test (6MWT) [ Time Frame: Baseline, 3-months, 6-months and 12-months ] [ Designated as safety issue: No ]
    Absolute change relative to baseline at 3-months, 6-months and 12-months for 6MWT

  • Quality of life as assessed by the St George's Respiratory Questionnaire (SGRQ) [ Time Frame: Baseline, 3-months, 6-months and 12-months ] [ Designated as safety issue: No ]
    Absolute change relative to baseline at 3-months, 6-months and 12-months for SGRQ

  • Dyspnea as assessed by the Modified Medical Research Council Dyspnea Score (mMRC) [ Time Frame: Baseline, 3-months, 6-months and 12-months ] [ Designated as safety issue: No ]
    Absolute change relative to baseline at 3-months, 6-months and 12-months for mMRC

  • Lobar volume reduction [ Time Frame: 3-months ] [ Designated as safety issue: Yes ]
    Lobar volume reduction of the treated lobes as quantified by computerized tomography (CT) scans at 3-months

  • Radiological signs of complications on computerized tomography (CT) scans [ Time Frame: 3-months following the second placement of AeriSeal foam. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: September 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AeriSeal System
Subjects will be treated with AeriSeal Foam.
Device: AeriSeal System
Subjects will undergo two bronchoscopy procedures two months apart and will be treated with AeriSeal foam unilaterally, in two sub-segments during each bronchoscopy (4 segments treated in total).

Detailed Description:
The AeriSeal-STAGE trial will be a prospective, multicenter study that intends to evaluate the safety of a modified staged treatment algorithm with an escalation of dose using the AeriSeal System in the treatment of subjects with severe emphysema in a controlled trial design setting as compared to published data from prior studies. The trial is anticipated to enroll fifteen (15) study subjects with homogeneous, or upper lobe predominant heterogeneous emphysema, in three (3) centers in Europe.
  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is willing and able to provide informed consent and to participate in the study
  2. Subject is ≥ 40 years of age
  3. Subject has a diagnosis of homogenous or heterogeneous upper lobe predominant emphysema confirmed by computerized tomography (CT) scan.
  4. Subject has at least two (2) non-adjacent subsegments appropriate for treatment based upon CT scan in 2 different upper lobe segments in each lung (total 4 available subsegments)
  5. Subject has clinically significant dyspnea scoring >1 on the mMRC scale of 0 - 4
  6. Subject has a Six-Minute Walk Test (6MWT) distance ≥ 250 meters
  7. Subject has post-bronchodilator FEV1 ≤ 45% predicted
  8. Subject has Total Lung Capacity >100% predicted
  9. Subject has Residual Volume >175% predicted
  10. Subject has stopped smoking for at least 8 weeks prior to entering the study as confirmed by carboxyhemoglobin or cotinine levels
  11. Subject has received preventive vaccinations against potential respiratory infections consistent with local recommendations or policy

Exclusion Criteria:

  1. Subject has severe bullous emphysema as judged by Investigator.
  2. Subject has prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any type
  3. Subject has evidence of active respiratory infection
  4. Subject has an ongoing chronic obstructive pulmonary disease (COPD) exacerbation or bronchospasm
  5. Subject has a known allergy to the device components:

    1. Polyether block amide - PEBAX®
    2. Polyvinyl Alcohol
    3. Glutaraldehyde
  6. Subject requires ventilatory support (invasive or non-invasive)
  7. Subject has diffusing capacity of the lungs for carbon monoxide (DLco) < 20% predicted
  8. Subject has a post-bronchodilator FEV1 < 20% predicted
  9. Subject cannot tolerate corticosteroids or relevant antibiotics
  10. Subject has relevant comorbidities as judged by the Investigator, or is deconditioned and cannot tolerate the stress of post-treatment inflammatory response
  11. Subject has a history of recurrent clinically significant respiratory infections, defined as three (3) or more COPD exacerbations requiring hospitalization during the year prior to enrollment
  12. Subject has severe gas exchange abnormalities as defined by any one of the following:

    1. Partial pressure of arterial carbon dioxide (PaCO2) >55 mm Hg
    2. Partial pressure arterial oxygen (PaO2) <45 mm Hg on room air
    3. Peripheral capillary oxygen saturation (SpO2) < 90% on ≥ 4 L/min supplemental O2, at rest
  13. Subject has Pulmonary hypertension, defined as peak systolic pressure > 45 mm Hg on echocardiogram or right heart catheterization
  14. Subject use of systemic steroids > 20 mg/day or equivalent, immunosuppressive agents, heparins, oral anticoagulants (e.g., warfarin, dicumarol; note: antiplatelet drugs including aspirin and clopidogrel are permitted) within 4 weeks of entering the study
  15. Subject has alpha1 -antitrypsin serum level of <80 mg/kg (i.e. < 11 µmol/L) at Screening
  16. Subject's CT scan indicates the presence of any the following radiologic abnormalities:

    1. Pulmonary nodule on CT scan greater than 0.8 cm in diameter [Does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/positron emission tomography (PET)]
    2. Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate
    3. Significant interstitial lung disease
    4. Significant pleural disease
  17. Subject's baseline electrocardiogram (EKG) indicates arrhythmias or conduction abnormalities
  18. Subject has high cardiac risk after undergoing cardiac risk assessment in accordance with published guidelines or ischemic heart disease, congestive heart failure, renal failure or cerebrovascular disease
  19. Clinically significant asthma (reversible airway obstruction), chronic bronchitis, or bronchiectasis
  20. Allergy or sensitivity to medications required to safely perform bronchoscopy and the AeriSeal System treatment under general anesthesia or conscious sedation
  21. Participation in an investigational study of a drug, biologic, or device within 30 days prior to entering the study or planned during the course of the study.
  22. Body mass index (BMI) < 15 kg/m2 or > 35 kg/m2
  23. Female subject pregnant or breast-feeding
  24. Abnormal screening laboratory test results as compared to reference lab normals at individual sites as follows:

    1. Blood urea nitrogen > 1.5 x upper limit of normal
    2. Creatinine > 1.5 x upper limit of normal
    3. Aspartate aminotransferase > 1.5 x upper limit of normal
    4. Alanine aminotransferase > 1.5 x upper limit of normal
    5. Alkaline phosphatase > 1.5 x upper limit of normal
    6. White blood cells (total) absolute < 3 x 109/L or > 1.25 x upper limit of normal
    7. Hematocrit < 34 or > 1.25 x upper limit of normal
    8. Platelets < 100 or > 450 K/µL
    9. Prothrombin time or International Normalized Ratio (INR) > 1.5 x upper limit of normal
    10. Partial thromboplastin time > 1.5x upper limit of normal
    11. Positive Beta human chorionic gonadotropin (β-HCG) Pregnancy test (if female)
  25. Subject has evidence of severe disease which in the judgment of the investigator may compromise survival for the duration of the study (24 months) e.g.:

    1. Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)
    2. Active malignancy
    3. Stroke or Transient ischemic attack (TIA) within 12 months of Screening visit
    4. Myocardial infarction within 6 months of Screening visit
    5. Congestive heart failure within 6 months of Screening visit defined as clinical evidence of right or left heart failure or left ventricular ejection fraction < 45% on echocardiogram

25) Subject has been diagnosed with diabetes mellitus 26) Any condition that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject i.e., alcoholism, high risk for drug abuse or noncompliance in returning for follow-up visits

  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: NCT02877459

Contacts
Contact: Narinder Shargill, PhD +1 650 216 0108 nshargill@pulmonx.com

Locations
Austria
Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie Not yet recruiting
Wien, Austria, 1140
Principal Investigator: Arschang Valipour, MD         
Germany
Thoraxklinik am Universitäts klinikum Heidelberg Not yet recruiting
Heidelberg, Germany, 69126
Principal Investigator: Ralf Eberhardt, MD         
Netherlands
University Medical Center Groningen Not yet recruiting
Groningen, Netherlands, 9700 RB
Principal Investigator: Dirk-Jan Slebos, MD         
Sponsors and Collaborators
Pulmonx, Inc.
Investigators
Study Director: Narinder Shargill, PhD Pulmonx, Inc.
  More Information

Responsible Party: Pulmonx, Inc.
ClinicalTrials.gov Identifier: NCT02877459     History of Changes
Other Study ID Numbers: 630-0019 
Study First Received: August 19, 2016
Last Updated: August 24, 2016
Health Authority: Germany: Ethics Commission
Netherlands: Independent Ethics Committee
Austria: Ethikkommission
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Emphysema
Pathologic Processes

ClinicalTrials.gov processed this record on December 09, 2016