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EmphysemaNCT01719263

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

A study testing InterVapor® treatment plus Optimal Medical Therapy and Optimal Medical Therapy in people with Emphysema, run by Uptake Medical Corp at 17 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Emphysema
What is being tested?
InterVapor® treatment plus Optimal Medical Therapy and Optimal Medical Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
17 sitesin 6 countries
Study dates
Jun 2013to Oct 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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%
Show all 9Show fewer
  • Stroke
  • Myocardial infarction or acute coronary syndrome in previous year
  • Hospitalization due to left ventricular failure in previous 3 years

Trial locations and contacts

17 sites in 6 countries.

17 sites in 6 countries

Germany9 sites

  • Charite Universitätsmedizin Berlin Campus Mitte

    Berlin, 10117

  • Gemeinschaftskrankenhaus Havelhöhe Berlin

    Berlin, 14089

  • Asklepios Fachkliniken Gauting München

    Gauting, 82131

  • Klinik Schillerhohe

    Gerlingen

  • Universitätsklinik Halle

    Halle

  • Asklepios Klinik Harburg

    Hamburg, 21075

  • Thoraxklinik Heidelberg

    Heidelberg, 69126

  • Lungenklinik Hemer

    Hemer, 58675

  • Klinikum Nürnberg

    Nuremberg, 90419

Other trials in Germany

Australia4 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Prince Charles Hospital

    Chermside, Queensland, 4032

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

Other trials in Australia

Austria1 site

  • Otto-Wagner-Spital

    Vienna, 1140

Other trials in Austria

Ireland1 site

  • Mater Misericordiae University Hospital

    Dublin, 7

Other trials in Ireland

New Zealand1 site

  • Auckland City Hospital

    Auckland, 1051

Other trials in New Zealand

United Kingdom1 site

  • Royal Bromptom & Harefield NHS Foundation

    London

Other trials in United Kingdom

About this study

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.

Conditions
Emphysema
Being tested
InterVapor® treatment plus Optimal Medical Therapy, Optimal Medical Therapy
Keywords
emphysema, InterVapor, treatments, pulmonary rehabilitation, lung volume reduction, endoscopic lung volume reduction
Medical subject headings
Emphysema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterVapor® treatment plus Optimal Medical TherapyDevice

    Also called InterVapor or BTVA

    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 TherapyOther

    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).

Study groups in NCT01719263
Study groupRoleWhat they receive
Treatment plus Optimal Medical TherapyExperimentalPatients will be treated with the InterVapor System and Optimal Medical Therapy
Receives: Device: InterVapor® treatment plus Optimal Medical Therapy
Optimal Medical TherapyActive comparatorPatients will be treated according to Optimal Medical Therapy
Receives: Other: Optimal Medical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Forced expiratory volume in 1-second (FEV1) compared to active comparator

    Measured: Year 1

  2. Quality of Life (SGRQ)

    Measured: Year 1

Secondary outcomes (4)

  1. Responder rate for FEV1 % difference from baseline

    Measured: Year 1

  2. Responder rate SGRQ pts difference from baseline

    Measured: Year 1

  3. Responder rate 6MWD meter difference from baseline

    Measured: Year 1

  4. Lobar Volume Reduction HRCT

    Measured: Year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2012 (estimated)
  2. Study startJun 2013
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01719263
Sponsor's protocol ID
CSP-1570
Status last verified
Oct 2015
First submitted
26 Oct 2012
Last updated
29 Oct 2015
Results posted
No
Data monitoring committee
No

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.

    PubMed 26899390

  • 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.

    PubMed 25500669

  • 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.

    PubMed 25467378

Questions about this trial

What is this clinical trial studying?

A study testing InterVapor® treatment plus Optimal Medical Therapy and Optimal Medical Therapy in people with Emphysema, run by Uptake Medical Corp at 17 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Germany, Australia, Austria, Ireland, New Zealand and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced expiratory volume in 1-second (FEV1) compared to active comparator (time frame: Year 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01719263, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015.

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