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Completed

NCT Number: NCT01102712

Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

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.

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Key information

Conditions

Emphysema Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince Charles Hospital, Chermside, Queensland, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: > 40 and ≤ 75 years old
  • Diagnosis of heterogeneous emphysema with upper lobe predominance
  • FEV1 < 45% predicted
  • TLC > 100% predicted
  • RV > 150% predicted
  • 6-minute walk test > 140 meters
  • mMRC ≥ 2 (mMRC)
  • Non-smoking for 3 months
  • Optimized medical management and completed pulmonary rehabilitation

Exclusion criteria

  • Known α-1-antitrypsin deficiency
  • BMI < 15 kg/m2 or > 35 kg / m2
  • History of pneumothorax within previous 18 months
  • History of heart and / or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, and/or lobectomy
  • Respiratory infections or recurring COPD exacerbations > 3 hospitalizations in past 12 months or active infection
  • 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

Treatment and study plan

BTVA System

Device

Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction

Primary outcomes

  1. increase in FEV1 ≥ 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score ≥ 4 points

    Time frame: 6 months

Secondary outcomes

  1. Lobar volume reduction as determined by computed tomography (CT) analysis

    Time frame: 3 months

  2. Changes in pulmonary function therapy

    Time frame: 3 months

  3. Improvement in 6 minute walk distance

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Uptake Medical Corp

Industry

Registry information

Official study title

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

Acronym: BTVA

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Apr 13, 2010
Registry last updated
Feb 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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