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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.
 
ClinicalTrials.gov Identifier: NCT01102712
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : February 23, 2012
Sponsor:
Information provided by (Responsible Party):
Uptake Medical Corp

Tracking Information
First Submitted Date  ICMJE April 8, 2010
First Posted Date  ICMJE April 13, 2010
Last Update Posted Date February 23, 2012
Study Start Date  ICMJE November 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2010)
increase in FEV1 ≥ 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score ≥ 4 points [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction
Official Title  ICMJE Evaluation Study of Unilateral Bronchoscopic Thermal Vapor Ablation (BTVA) in Patients With Heterogeneous Emphysema and Upper Lobe Predominance
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Emphysema
  • Chronic Obstructive Pulmonary Disease
Intervention  ICMJE Device: BTVA System
Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction
Study Arms  ICMJE Experimental: BTVA
Intervention: Device: BTVA System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2012)
34
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2010)
30
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Germany,   Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01102712
Other Study ID Numbers  ICMJE Vapor-OUS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Uptake Medical Corp
Study Sponsor  ICMJE Uptake Medical Corp
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Uptake Medical Corp
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP