Bronchoscopic Vapour Therapy for Emphysema (unilateral treatment)

The Effect of Unilateral Bronchoscopic Thermal Vapour Ablation (BTVA) on Pulmonary Function and Quality of Life in Patients with with Heterogeneous Emphysema and Upper Lobe Predominance

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000822280

Enrollment

Registered

2009-09-21

Start date

2009-10-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of this study is to evaluate the safety and effectiveness of a unilateral application of bronchoscopic thermal vapour ablation for improvement in function and demonstrate reduction of lung volume 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 3 lung segments from one lung lobe, either the right or left upper lobes, will be treated in one procedure. Patients will receive a prescribed amount of vapour (target vapour dose) delivered to the identified lung segments of 10 calories per gram of lung tissue. The total time of the BTVA procedure is expected to be< 45 minutes.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

Heterogeneous emphysema with upper lobe predominance confirmed by computerized tomography (CT); ability 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; previous history of unstable myocardial ischemia; FEV1 < 15%, DLCO < 20%

Outcome results