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

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. Identifier: NCT01041586
Recruitment Status : Completed
First Posted : December 31, 2009
Last Update Posted : February 23, 2012
Information provided by (Responsible Party):
Uptake Medical Corp

Brief Summary:
To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous upper lobe emphysema.

Condition or disease Intervention/treatment Phase
Emphysema Chronic Obstructive Pulmonary Disease Device: BTVA System Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Study Start Date : December 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
Experimental: BTVA Device: BTVA System
Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
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

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 identifier (NCT number): 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

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
First Posted: December 31, 2009    Key Record Dates
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