- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01719263
Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study
October 27, 2015 updated by: Uptake Medical Corp
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Queensland
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Chermside, Queensland, Australia, 4032
- Prince Charles Hospital
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
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Victoria
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Melbourne, Victoria, Australia, 3004
- The Alfred Hospital
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital
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Vienna, Austria, 1140
- Otto-Wagner-Spital
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Berlin, Germany, 10117
- Charite Universitätsmedizin Berlin Campus Mitte
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Berlin, Germany, 14089
- Gemeinschaftskrankenhaus Havelhöhe Berlin
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Gauting, Germany, 82131
- Asklepios Fachkliniken Gauting München
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Gerlingen, Germany
- Klinik Schillerhohe
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Halle, Germany
- Universitätsklinik Halle
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Hamburg, Germany, 21075
- Asklepios Klinik Harburg
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Heidelberg, Germany, 69126
- Thoraxklinik Heidelberg
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Hemer, Germany, 58675
- Lungenklinik Hemer
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Nuernberg, Germany, 90419
- Klinikum Nürnberg
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Dublin, Ireland, 7
- Mater Misericordiae University Hospital
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Auckland, New Zealand, 1051
- Auckland City Hospital
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London, United Kingdom
- Royal Bromptom & Harefield NHS Foundation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Treatment plus Optimal Medical Therapy
Patients will be treated with the InterVapor System and Optimal Medical Therapy
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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 Names:
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Active Comparator: Optimal Medical Therapy
Patients will be treated according to Optimal Medical Therapy
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Forced expiratory volume in 1-second (FEV1) compared to active comparator
Time Frame: Year 1
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Year 1
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Quality of Life (SGRQ)
Time Frame: Year 1
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Year 1
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Responder rate for FEV1 % difference from baseline
Time Frame: Year 1
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Year 1
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Responder rate SGRQ pts difference from baseline
Time Frame: Year 1
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Year 1
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Responder rate 6MWD meter difference from baseline
Time Frame: Year 1
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Year 1
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Lobar Volume Reduction HRCT
Time Frame: Year 1
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Year 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Felix JF Herth, MD, Heidelberg University
- Principal Investigator: Gregory Snell, MD, The Alfred Hospital, Melbourne, Australia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Herth FJ, Valipour A, Shah PL, Eberhardt R, Grah C, Egan J, Ficker JH, Wagner M, Witt C, Liebers U, Hopkins P, Gesierich W, Phillips M, Stanzel F, McNulty WH, Petermann C, Snell G, Gompelmann D. Segmental volume reduction using thermal vapour ablation in patients with severe emphysema: 6-month results of the multicentre, parallel-group, open-label, randomised controlled STEP-UP trial. Lancet Respir Med. 2016 Mar;4(3):185-93. doi: 10.1016/S2213-2600(16)00045-X. Epub 2016 Feb 16.
- Bandyopadhyay S, Henne E, Gupta A, Barry R, Snell G, Strange C, Herth FJ. Segmental approach to lung volume reduction therapy for emphysema patients. Respiration. 2015;89(1):76-81. doi: 10.1159/000369036. Epub 2014 Dec 6.
- Valipour A, Herth FJ, Eberhardt R, Shah PL, Gupta A, Barry R, Henne E, Bandyopadhyay S, Snell G. Design of the randomized, controlled sequential staged treatment of emphysema with upper lobe predominance (STEP-UP) study. BMC Pulm Med. 2014 Dec 3;14:190. doi: 10.1186/1471-2466-14-190.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
October 26, 2012
First Submitted That Met QC Criteria
October 29, 2012
First Posted (Estimate)
November 1, 2012
Study Record Updates
Last Update Posted (Estimate)
October 29, 2015
Last Update Submitted That Met QC Criteria
October 27, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSP-1570
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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