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

Study Overview
=================
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.

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

Conditions
-----------------
Emphysema

Intervention / Treatment
-----------------
* Device: InterVapor® treatment plus Optimal Medical Therapy
* Other: Optimal Medical Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment plus Optimal Medical Therapy<br>Patients will be treated with the InterVapor System and Optimal Medical Therapy | Device: InterVapor® treatment plus Optimal Medical Therapy<br>* 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).<br>* Other names: InterVapor or BTVA;|
| Active Comparator: Optimal Medical Therapy<br>Patients will be treated according to Optimal Medical Therapy | Other: Optimal Medical Therapy<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in 1-second (FEV1) compared to active comparator |  | Year 1 | 
| Quality of Life (SGRQ) |  | Year 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate for FEV1 % difference from baseline |  | Year 1 | 
| Responder rate SGRQ pts difference from baseline |  | Year 1 | 
| Responder rate 6MWD meter difference from baseline |  | Year 1 | 
| Lobar Volume Reduction HRCT |  | Year 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emphysema, InterVapor, treatments, pulmonary rehabilitation, lung volume reduction, endoscopic lung volume reduction