NCT01719263

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Uptake Medical Corp · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2012-11-01
• Last updated: 2015-10-29

Locations

17 sites across 6 countries: Australia, Austria, Germany, Ireland, New Zealand, United Kingdom