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Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction (BTVA)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 13, 2010
Last Update Posted: February 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Uptake Medical Corp
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.

Condition Intervention
Emphysema Chronic Obstructive Pulmonary Disease Device: BTVA System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation Study of Unilateral Bronchoscopic Thermal Vapor Ablation (BTVA) in Patients With Heterogeneous Emphysema and Upper Lobe Predominance

Resource links provided by NLM:

Further study details as provided by Uptake Medical Corp:

Primary Outcome Measures:
  • increase in FEV1 ≥ 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score ≥ 4 points [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Lobar volume reduction as determined by computed tomography (CT) analysis [ Time Frame: 3 months ]
  • Changes in pulmonary function therapy [ Time Frame: 3 months ]
  • Improvement in 6 minute walk distance [ Time Frame: 3 months ]

Enrollment: 34
Study Start Date: November 2009
Study Completion Date: August 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BTVA Device: BTVA System
Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction

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.

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102712

Australia, Queensland
Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3181
LKH Klagenfurt
Klagenfurt, Austria, 9020
Otto-Wagner Hospital
Wien, Austria, 1140
Zentralklinik Bad Berka
Bad Berka, Germany, 99437
Charite Campus Mitte
Berlin, Germany, 10117
Thoraxklinik Heidelberg
Heildelberg, Germany, 69126
Abteilung fur Pneumologie
Hemer, Germany, 58675
Klinikum Nurnberg
Nurnberg, Germany, 90419
Mater Misericordiae University Hospital
Dublin, Ireland, 7
Sponsors and Collaborators
Uptake Medical Corp
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Uptake Medical Corp
ClinicalTrials.gov Identifier: NCT01102712     History of Changes
Other Study ID Numbers: Vapor-OUS
First Submitted: April 8, 2010
First Posted: April 13, 2010
Last Update Posted: February 23, 2012
Last Verified: February 2012

Keywords provided by Uptake Medical Corp:
Lung Volume Reduction

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Emphysema
Respiratory Tract Diseases
Pathologic Processes