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

Uptake Medical

Status: Completed

Conditions: Emphysema

Treatments: Other: Optimal Medical Therapy; Device: InterVapor® treatment plus Optimal Medical Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01719263

CSP-1570

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

69 participants in 2 patient groups

Treatment plus Optimal Medical Therapy

Experimental group

Description:

Patients will be treated with the InterVapor System and Optimal Medical Therapy

Treatment:

Device: InterVapor® treatment plus Optimal Medical Therapy

Optimal Medical Therapy

Active Comparator group

Description:

Patients will be treated according to Optimal Medical Therapy

Treatment:

Other: Optimal Medical Therapy