None listed
Conditions
Brief summary
The primary purpose of this study is to established the side effect and benefit profile of BTVA in patients with heterogeneous upper lobe emphysema. The results will help to support subsequent clinical trials in a larger patient sample.
Interventions
Vapour (steam) is infused into a targeted emphysematous lung segment for approximately 4-8 seconds. No more than 3 segments within 1 lobe of a lung will be treated. The 3 segments will be treated in one procedure, with a waiting time of at least 4 minutes between each vapour treatment. The total time of the BTVA procedure is expected to be 1.5 hours.
Sponsors
Uptake Medical Corp.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients diagnosed with heterogeneous emphysema with upper lobe predominance as evidence by Computed Tomography (CT) imaging FEV1 > 45% predicted; Total Lung Capacity (TLC) / 100% predicted; Residual Volume (RV) > 150% predicted Exercise Capacity: Ability to walk > 140 metres in 6 minutes after completing a pulmonary rehabilitation program Non-smoking for 4 months prior to study enrollment Dyspnea scoring > or = 2 (of 4)
Exclusion criteria
Patients diagnosed with homogeneous emphysema or heterogeneous emphysema with lower lobe predominance Known alpha-1 antityrpsin deficiency Body Mass Index (BMI) < 15kg/m2 or > 35 kg/m2 - body mass index is the relationship between weight and height that is associated with body fat and health risk Clinically significant asthma, chronic bronchitis or bronchiectasis Patients with heart/lung transplant or prior lung volume reduction surgery Patients with significant pulmonary hypertension, heart disease or history of stroke
Outcome results
None listed