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

N/ACompletedNCT01719263

Uptake Medical Corp69 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Emphysema

Interventions

InterVapor® treatment plus Optimal Medical TherapyDEVICE

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).

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (17)

Prince Charles Hospital

Chermside, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

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

Time frame: Year 1

Quality of Life (SGRQ)

Time frame: Year 1

Secondary Outcomes

Responder rate for FEV1 % difference from baseline

Time frame: Year 1

Responder rate SGRQ pts difference from baseline

Time frame: Year 1

Responder rate 6MWD meter difference from baseline

Time frame: Year 1

Lobar Volume Reduction HRCT

Time frame: Year 1

Data from ClinicalTrials.gov

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