Clinical trial NCT01102712: Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction
Official title: Evaluation Study of Unilateral Bronchoscopic Thermal Vapor Ablation (BTVA) in Patients With Heterogeneous Emphysema and Upper Lobe Predominance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emphysema
Chronic Obstructive Pulmonary Disease
Keywords: Emphysema
COPD
Lung Volume Reduction
BTVA
Lead sponsor: Uptake Medical Corp
Sponsor class: INDUSTRY
First posted: 2010-04-13
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: increase in FEV1 ≥ 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score ≥ 4 points
timeFrame: 6 months
Secondary outcomes:
measure: Lobar volume reduction as determined by computed tomography (CT) analysis
timeFrame: 3 months
measure: Changes in pulmonary function therapy
timeFrame: 3 months
measure: Improvement in 6 minute walk distance
timeFrame: 3 months
Other outcomes:
Locations:
city: Chermside
country: Australia
facility: Prince Charles Hospital
state: Queensland
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Klagenfurt
country: Austria
facility: LKH Klagenfurt
city: Wien
country: Austria
facility: Otto-Wagner Hospital
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Berlin
country: Germany
facility: Charite Campus Mitte
city: Heildelberg
country: Germany
facility: Thoraxklinik Heidelberg
city: Hemer
country: Germany
facility: Abteilung fur Pneumologie
city: Nurnberg
country: Germany
facility: Klinikum Nurnberg
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
Study officials:
References:
citation: Herth FJ, Ernst A, Baker KM, Egan JJ, Gotfried MH, Hopkins P, Stanzel F, Valipour A, Wagner M, Witt C, Kesten S, Snell G. Characterization of outcomes 1 year after endoscopic thermal vapor ablation for patients with heterogeneous emphysema. Int J Chron Obstruct Pulmon Dis. 2012;7:397-405. doi: 10.2147/COPD.S31082. Epub 2012 Jul 18.
citation: Snell G, Herth FJ, Hopkins P, Baker KM, Witt C, Gotfried MH, Valipour A, Wagner M, Stanzel F, Egan JJ, Kesten S, Ernst A. Bronchoscopic thermal vapour ablation therapy in the management of heterogeneous emphysema. Eur Respir J. 2012 Jun;39(6):1326-33. doi: 10.1183/09031936.00092411. Epub 2011 Nov 10.