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

February 21, 2012 updated by: Uptake Medical Corp

Evaluation Study of Unilateral Bronchoscopic Thermal Vapor Ablation (BTVA) in Patients With Heterogeneous Emphysema and Upper Lobe Predominance

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BTVA
Device: BTVA System
Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uptake Medical Corp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (ESTIMATE)

April 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2012

Last Update Submitted That Met QC Criteria

February 21, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vapor-OUS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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