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Completed

NCT Number: NCT01719263

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

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Key information

Conditions

Emphysema Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince Charles Hospital, Chermside, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

InterVapor® treatment plus Optimal Medical Therapy

Device

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 names: InterVapor or BTVA

Optimal medical therapy

Other

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).

Primary outcomes

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

    Time frame: Year 1

  2. Quality of Life (SGRQ)

    Time frame: Year 1

Secondary outcomes

  1. Responder rate for FEV1 % difference from baseline

    Time frame: Year 1

  2. Responder rate SGRQ pts difference from baseline

    Time frame: Year 1

  3. Responder rate 6MWD meter difference from baseline

    Time frame: Year 1

  4. Lobar Volume Reduction HRCT

    Time frame: Year 1

Sponsors and collaborators

Lead sponsor

Uptake Medical Corp

Industry

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 1, 2012
Registry last updated
Oct 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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