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Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study

This study is not yet open for participant recruitment.
Verified May 2013 by Uptake Medical Corp
Sponsor:
Information provided by (Responsible Party):
Uptake Medical Corp
ClinicalTrials.gov Identifier:
NCT01719263
First received: October 26, 2012
Last updated: May 22, 2013
Last verified: May 2013
History of Changes
  Purpose

This study is designed to demonstrate safety and efficacy in patients with severe upper lobe predominant emphysema. For validity of the study, the results will be compared to patients that receive optimal medical therapy.


Condition Intervention
Emphysema
 Device: InterVapor® treatment plus Optimal Medical Therapy
Other: Optimal Medical Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study

Resource links provided by NLM:

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Further study details as provided by Uptake Medical Corp:

Primary Outcome Measures:
  • Forced expiratory volume in 1-second (FEV1) compared to active comparator [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Quality of Life (SGRQ) [ Time Frame: Year 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Responder rate for FEV1 % difference from baseline [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Responder rate SGRQ pts difference from baseline [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Responder rate 6MWD meter difference from baseline [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Lobar Volume Reduction HRCT [ Time Frame: Year 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 69
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment plus Optimal Medical Therapy
Patients will be treated with the InterVapor System and Optimal Medical Therapy
 Device: InterVapor® treatment plus Optimal Medical Therapy
Patients will be treated with the InterVapor System in 1 to 2 segments in the upper lobes of each lung (2 to 3 segments total). Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
Other Name: InterVapor or BTVA
Active Comparator: Optimal Medical Therapy
Patients will be treated according to Optimal Medical Therapy
 Other: Optimal Medical Therapy
Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heterogeneous emphysema with upper lobe predominance in both lungs
  • FEV1 between 20% and 45% predicted
  • Residual volume (RV) > 150% predicted
  • Post-rehabilitation 6-minute walk test > 140 meters

Exclusion Criteria:

  • More than 3 COPD related hospitalizations requiring antibiotics in past 12 months
  • FEV1 < 20% predicted
  • DLCO < 20% predicted or immeasurable DLCO
  • Body mass index (BMI) < 18kg/m2 or > 32 kg/m2

  • History of any of the following:

    • Left ventricular ejection fraction (EF) ≤ 40%
    • Stroke
    • Myocardial infarction or acute coronary syndrome in previous year
    • Hospitalization due to left ventricular failure in previous 3 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719263

Sponsors and Collaborators
Uptake Medical Corp
Investigators
Principal Investigator: Felix JF Herth, MD University of Heidelberg
Principal Investigator: Gregory Snell, MD The Alfred Hospital, Melbourne, Australia
  More Information

No publications provided

Responsible Party: Uptake Medical Corp
ClinicalTrials.gov Identifier: NCT01719263     History of Changes
Other Study ID Numbers: CSP-1570
Study First Received: October 26, 2012
Last Updated: May 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Uptake Medical Corp:
emphysema
InterVapor
treatments
 pulmonary rehabilitation
lung volume reduction
endoscopic lung volume reduction

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

ClinicalTrials.gov processed this record on June 18, 2013