Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

Evaluation Study of Unilateral Bronchoscopic Thermal Vapor Ablation (BTVA) in Patients With Heterogeneous Emphysema and Upper Lobe Predominance

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01102712

Acronym

BTVA

Enrollment

Registered

2010-04-13

Start date

2009-11-30

Completion date

2011-08-31

Last updated

2012-02-23

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

Conditions

Chronic Obstructive Pulmonary Disease, Emphysema

Keywords

Emphysema, COPD, Lung Volume Reduction, BTVA

Brief summary

To establish and confirm the safety and clinical utility of BTVA applied unilaterally for lung volume reduction in patients with upper lobe predominate heterogeneous severe emphysema.

Detailed description

All subjects meeting the eligibility criteria and who provide written informed consent will be enrolled. Up to 3 segments in either the right or left upper lobe will be treated with a vapor dose of 10 calories per gram of lung tissue (10 cal/g). Targeted lobe for treatment will be based on lobar disease severity.

Interventions

DEVICEBTVA System

Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Age: \> 40 and ≤ 75 years old 2. Diagnosis of heterogeneous emphysema with upper lobe predominance 3. FEV1 \< 45% predicted 4. TLC \> 100% predicted 5. RV \> 150% predicted 6. 6-minute walk test \> 140 meters 7. mMRC ≥ 2 (mMRC) 8. Non-smoking for 3 months 9. Optimized medical management and completed pulmonary rehabilitation

Exclusion criteria

1. Known α-1-antitrypsin deficiency 2. BMI \< 15 kg/m2 or \> 35 kg / m2 3. History of pneumothorax within previous 18 months 4. History of heart and / or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, and/or lobectomy 5. Respiratory infections or recurring COPD exacerbations \> 3 hospitalizations in past 12 months or active infection 6. History of the (EF) ≤ 40%; Stroke; Unstable Myocardial Ischemia; FEV1 \< 15% predicted; DLCO \< 20% predicted; pulmonary hypertension; indwelling pacemaker or implantable cardiac defibrillator (ICD); pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
increase in FEV1 ≥ 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score ≥ 4 points	6 months

Secondary

Measure	Time frame
Lobar volume reduction as determined by computed tomography (CT) analysis	3 months
Changes in pulmonary function therapy	3 months
Improvement in 6 minute walk distance	3 months

Countries

Australia, Austria, Germany, Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026