Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

Completed · Phase 1

Conditions studied: Emphysema, Chronic Obstructive Pulmonary Disease

In brief

To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous upper lobe emphysema.

Key facts

Study ID

NCT01041586

Run by

Uptake Medical Corp

People needed

10

Starts

2009-12-01

Expected to finish

2011-08-01

Last updated by the study team

2012-02-23

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: > 40 and ≤ 75 years old
• Diagnosis of heterogeneous emphysema with upper lobe predominance
• FEV1 < 45% predicted
• TLC > 100% predicted
• RV > 150% predicted
• 6-minute walk test > 140 meters
• mMRC ≥ 2 (mMRC)
• Non-smoking for 3 months
• Optimized medical management and completed pulmonary rehabilitation

You may not qualify if…

• Known α-1-antitrypsin deficiency
• BMI < 15 kg/m2 or > 35 kg / m2
• History of pneumothorax within previous 18 months
• History of heart and / or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, and/or lobectomy
• Respiratory infections or recurring COPD exacerbations > 3 hospitalizations in past 12 months or active infection
• History of the (EF) ≤ 40%; Stroke; Unstable Myocardial Ischemia; FEV1 < 15% predicted; DLCO < 20% predicted; of pulmonary hypertension; indwelling pacemaker or implantable cardiac defibrillator (ICD); pregnancy or breastfeeding

Where it is running

• John C. Lincoln Hospital — Phoenix, Arizona, United States
• University of Iowa — Iowa City, Iowa, United States
• Study site — Boston, Massachusetts, United States
• Swedish Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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