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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01719263




Registration number
NCT01719263
Ethics application status
Date submitted
26/10/2012
Date registered
1/11/2012
Date last updated
29/10/2015

Titles & IDs
Public title
Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study
Scientific title
Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study
Secondary ID [1] 0 0
CSP-1570
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emphysema 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - InterVapor® treatment plus Optimal Medical Therapy
Other interventions - Optimal Medical Therapy

Experimental: Treatment plus Optimal Medical Therapy - Patients will be treated with the InterVapor System and Optimal Medical Therapy

Active comparator: Optimal Medical Therapy - Patients will be treated according to Optimal Medical Therapy


Treatment: Devices: 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 interventions: 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).
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Forced expiratory volume in 1-second (FEV1) compared to active comparator
Timepoint [1] 0 0
Year 1
Primary outcome [2] 0 0
Quality of Life (SGRQ)
Timepoint [2] 0 0
Year 1
Secondary outcome [1] 0 0
Responder rate for FEV1 % difference from baseline
Timepoint [1] 0 0
Year 1
Secondary outcome [2] 0 0
Responder rate SGRQ pts difference from baseline
Timepoint [2] 0 0
Year 1
Secondary outcome [3] 0 0
Responder rate 6MWD meter difference from baseline
Timepoint [3] 0 0
Year 1
Secondary outcome [4] 0 0
Lobar Volume Reduction HRCT
Timepoint [4] 0 0
Year 1

Eligibility
Key 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
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Germany
State/province [3] 0 0
Gauting
Country [4] 0 0
Germany
State/province [4] 0 0
Gerlingen
Country [5] 0 0
Germany
State/province [5] 0 0
Halle
Country [6] 0 0
Germany
State/province [6] 0 0
Hamburg
Country [7] 0 0
Germany
State/province [7] 0 0
Heidelberg
Country [8] 0 0
Germany
State/province [8] 0 0
Hemer
Country [9] 0 0
Germany
State/province [9] 0 0
Nuernberg
Country [10] 0 0
Ireland
State/province [10] 0 0
Dublin
Country [11] 0 0
New Zealand
State/province [11] 0 0
Auckland
Country [12] 0 0
United Kingdom
State/province [12] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Uptake Medical Corp
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT01719263
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Felix JF Herth, MD
Address 0 0
Heidelberg University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01719263