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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Uptake Medical Corp
Sponsor:
Information provided by (Responsible Party):
Uptake Medical Corp
ClinicalTrials.gov Identifier:
NCT01719263
First received: October 26, 2012
Last updated: March 10, 2014
Last verified: March 2014
  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:


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
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: NCT01719263

Contacts
Contact: Carol Holt 9494401800 intervaporstepup@uptakemedical.com

Locations
Australia, Queensland
Prince Charles Hospital Recruiting
Chermside, Queensland, Australia, 4032
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia, 6009
Austria
Otto-Wagner-Spital Recruiting
Vienna, Austria, 1140
Germany
Gemeinschaftskrankenhaus Havelhöhe Berlin Recruiting
Berlin, Germany, 14089
Charite Universitätsmedizin Berlin Campus Mitte Recruiting
Berlin, Germany, 10117
Asklepios Fachkliniken Gauting München Recruiting
Gauting, Germany, 82131
Klinik Schillerhohe Recruiting
Gerlingen, Germany
Universitätsklinik Halle Recruiting
Halle, Germany
Asklepios Klinik Harburg Recruiting
Hamburg, Germany, 21075
Thoraxklinik Heidelberg Recruiting
Heidelberg, Germany, 69126
Lungenklinik Hemer Recruiting
Hemer, Germany, 58675
Klinikum Nürnberg Recruiting
Nuernberg, Germany, 90419
Ireland
Mater Misericordiae University Hospital Recruiting
Dublin, Ireland, 7
New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand, 1051
United Kingdom
Royal Bromptom & Harefield NHS Foundation Recruiting
London, United Kingdom
Sponsors and Collaborators
Uptake Medical Corp
Investigators
Principal Investigator: Felix JF Herth, MD Heidelberg University
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: March 10, 2014
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 July 20, 2014