None listed
Conditions
Brief summary
The primary purpose of this study is to evaluate the safety and effectivness of a bilateral application of bronchoscopic thermal vapour ablation (BTVA) for lung volume reduction in patients diagnosed with heterogeneous upper lobe emphysema.
Interventions
Vapour (steam) is infused into a targeted emphysematous lung segment for approximately 3 - 10 seconds. Up to 7 lung segments within the right and left upper lobes of the lung will be treated in one procedure. Patients in the first cohort will receive a prescribed amount of vapour (target vapour dose) delivered to each lung segment of 7.5 calories per gram of lung tissue. A second cohort of patients may be treated with a target vapour dose of 10 calories per gram of lung tissue after 3 month f
Vapour (steam) is infused into a targeted emphysematous lung segment for approximately 3 - 10 seconds. Up to 7 lung segments within the right and left upper lobes of the lung will be treated in one procedure. Patients in the first cohort will receive a prescribed amount of vapour (target vapour dose) delivered to each lung segment of 7.5 calories per gram of lung tissue. A second cohort of patients may be treated with a target vapour dose of 10 calories per gram of lung tissue after 3 month follow-up results are reviewed.
Sponsors
Uptake Medical Corp.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Heterogeneous emphysema with upper lobe predominance confirmed by computerized tomography (CT) and quantitative differential ventilation and perfusion scan; Able to walk at least 140 meters; non-smoking for 3 months prior to study enrollment; completed pulmonary rehabilitation program
Exclusion criteria
Known alpha 1 antitrypsin deficiency; previous heart or lung transplant or lung; previous history of unstable myocardial ischemia; FEV1 < 15%
Outcome results
None listed