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

This study has been completed.
Information provided by (Responsible Party):
Uptake Medical Corp Identifier:
First received: December 22, 2009
Last updated: February 21, 2012
Last verified: February 2012
To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous upper lobe emphysema.

Condition Intervention Phase
Emphysema Chronic Obstructive Pulmonary Disease Device: BTVA System Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: US Pilot Safety and Feasibility Study of Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction in Patients With Heterogeneous Emphysema With Upper Lobe Predominance

Resource links provided by NLM:

Further study details as provided by Uptake Medical Corp:

Primary Outcome Measures:
  • Occurence of adverse events (serious and non-serious) secondary to the BTVA treatment procedure from initiation of treatment through completion of the six-month follow-up period [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Radiographic evidence of lung volume reduction (assessed by study site radiologist) and CT scan (assessed by blinded radiologist at CT core lab) [ Time Frame: 6 months ]

Enrollment: 10
Study Start Date: December 2009
Study Completion Date: August 2011
Primary Completion Date: January 2011 (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. Immediately prior to BTVA treatment, an initial bronchoscopy will be performed to evaluate the baseline condition of the airways and to confirm anatomy of the lung segments targeted for BTVA treatment. 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.

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; of pulmonary hypertension; indwelling pacemaker or implantable cardiac defibrillator (ICD); pregnancy or breastfeeding
  Contacts and Locations
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Please refer to this study by its identifier: NCT01041586

United States, Arizona
John C. Lincoln Hospital
Phoenix, Arizona, United States
United States, Iowa
University of Iowa
Iowa City, Iowa, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Washington
Swedish Hospital
Seattle, Washington, United States
Sponsors and Collaborators
Uptake Medical Corp
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Uptake Medical Corp Identifier: NCT01041586     History of Changes
Other Study ID Numbers: VAPOR-US
Study First Received: December 22, 2009
Last Updated: February 21, 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 processed this record on September 20, 2017