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

NCT01719263 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2015-10-29

No results posted yet for this study

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.

Conditions

  • Emphysema

Interventions

DEVICE

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

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).

Sponsors & Collaborators

  • Uptake Medical Corp

    lead INDUSTRY

Principal Investigators

  • Felix JF Herth, MD · Heidelberg University

  • Gregory Snell, MD · The Alfred Hospital, Melbourne, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Australia
  • Austria
  • Germany
  • Ireland
  • New Zealand
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01719263 on ClinicalTrials.gov