Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study
NCT ID: NCT01719263
Last Updated: 2015-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
69 participants
INTERVENTIONAL
2013-06-30
2015-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Randomized Controlled Trial of InterVapor® in France - The TARGET Trial
NCT05118269
Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest
NCT02989168
Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease
NCT01559051
Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)
NCT01449292
A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis
NCT06280391
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment plus Optimal Medical Therapy
Patients will be treated with the InterVapor System and Optimal Medical Therapy
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).
Optimal Medical Therapy
Patients will be treated according to Optimal Medical Therapy
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
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).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* FEV1 between 20% and 45% predicted
* Residual volume (RV) \> 150% predicted
* Post-rehabilitation 6-minute walk test \> 140 meters
Exclusion Criteria
* 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
40 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Uptake Medical Corp
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Felix JF Herth, MD
Role: PRINCIPAL_INVESTIGATOR
Heidelberg University
Gregory Snell, MD
Role: PRINCIPAL_INVESTIGATOR
The Alfred Hospital, Melbourne, Australia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Prince Charles Hospital
Chermside, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Otto-Wagner-Spital
Vienna, , Austria
Charite Universitätsmedizin Berlin Campus Mitte
Berlin, , Germany
Gemeinschaftskrankenhaus Havelhöhe Berlin
Berlin, , Germany
Asklepios Fachkliniken Gauting München
Gauting, , Germany
Klinik Schillerhohe
Gerlingen, , Germany
Universitätsklinik Halle
Halle, , Germany
Asklepios Klinik Harburg
Hamburg, , Germany
Thoraxklinik Heidelberg
Heidelberg, , Germany
Lungenklinik Hemer
Hemer, , Germany
Klinikum Nürnberg
Nuremberg, , Germany
Mater Misericordiae University Hospital
Dublin, , Ireland
Auckland City Hospital
Auckland, , New Zealand
Royal Bromptom & Harefield NHS Foundation
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CSP-1570
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.