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

Not Applicable

Completed

• Conditions: Emphysema
• Interventions: Device: InterVapor® treatment plus Optimal Medical Therapy; Other: Optimal Medical Therapy

• Registration Number: NCT01719263
• Lead Sponsor: Uptake Medical Corp

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-26
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-11-01
• Study Start: 2013-06
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-27
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment plus Optimal Medical Therapy	InterVapor® treatment plus Optimal Medical Therapy	Patients will be treated with the InterVapor System and Optimal Medical Therapy
Optimal Medical Therapy	Optimal Medical Therapy	Patients will be treated according to Optimal Medical Therapy

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume in 1-second (FEV1) compared to active comparator	Year 1
Quality of Life (SGRQ)	Year 1

Secondary Outcome Measures

Name	Time	Method
Responder rate for FEV1 % difference from baseline	Year 1
Responder rate 6MWD meter difference from baseline	Year 1
Responder rate SGRQ pts difference from baseline	Year 1
Lobar Volume Reduction HRCT	Year 1

Trial Locations

Locations (17)

Otto-Wagner-Spital; 🇦🇹 Vienna, Austria

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Sir Charles Gairdner Hospital; 🇦🇺 Nedlands, Western Australia, Australia

Gemeinschaftskrankenhaus Havelhöhe Berlin; 🇩🇪 Berlin, Germany

Charite Universitätsmedizin Berlin Campus Mitte; 🇩🇪 Berlin, Germany

Klinik Schillerhohe; 🇩🇪 Gerlingen, Germany

Universitätsklinik Halle; 🇩🇪 Halle, Germany

Asklepios Klinik Harburg; 🇩🇪 Hamburg, Germany

Thoraxklinik Heidelberg; 🇩🇪 Heidelberg, Germany

Klinikum Nürnberg; 🇩🇪 Nuernberg, Germany

Lungenklinik Hemer; 🇩🇪 Hemer, Germany

Mater Misericordiae University Hospital; 🇮🇪 Dublin, Ireland

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Royal Bromptom & Harefield NHS Foundation; 🇬🇧 London, United Kingdom

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Asklepios Fachkliniken Gauting München; 🇩🇪 Gauting, Germany

Prince Charles Hospital; 🇦🇺 Chermside, Queensland, Australia