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Completed

NCT Number: NCT01041586

Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

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

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

John C. Lincoln Hospital, Phoenix, Arizona, United States

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About this study

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.

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; of 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. 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Uptake Medical Corp

Industry

Registry information

Official study 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

Acronym: BTVA

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 31, 2009
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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