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Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Uptake Medical Corp
ClinicalTrials.gov Identifier:
NCT01102712
First received: April 8, 2010
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lobar volume reduction as determined by computed tomography (CT) analysis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102712

Locations
Australia, Queensland
Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3181
Austria
LKH Klagenfurt
Klagenfurt, Austria, 9020
Otto-Wagner Hospital
Wien, Austria, 1140
Germany
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
Ireland
Mater Misericordiae University Hospital
Dublin, Ireland, 7
Sponsors and Collaborators
Uptake Medical Corp
  More Information

No publications provided by Uptake Medical Corp

Additional 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
Study First Received: April 8, 2010
Last Updated: February 21, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Uptake Medical Corp:
Emphysema
COPD
Lung Volume Reduction
BTVA

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

ClinicalTrials.gov processed this record on November 20, 2014