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CompletedNCT01102712BTVAUpdated Feb 23, 2012

Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

An interventional study of BTVA System in Emphysema and Chronic Obstructive Pulmonary Disease, sponsored by Uptake Medical Corp. Completed at 10 sites in 4 countries. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-02-23.

Sponsored by Uptake Medical Corp · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Emphysema
  • Chronic Obstructive Pulmonary Disease

Keywords

  • Emphysema
  • COPD
  • Lung Volume Reduction
  • BTVA
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 34 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Uptake Medical Corp is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    BTVA

    Device: BTVA System

Interventions

  • DeviceBTVA System

    Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction

06

What researchers measure

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

07

Study locations

10 sites
  • Prince Charles Hospital
    Chermside, Queensland 4032, Australia
  • The Alfred Hospital
    Melbourne, Victoria 3181, Australia
  • LKH Klagenfurt
    Klagenfurt, 9020, Austria
  • Otto-Wagner Hospital
    Wien, 1140, Austria
  • Zentralklinik Bad Berka
    Bad Berka, 99437, Germany
  • Charite Campus Mitte
    Berlin, 10117, Germany
  • Thoraxklinik Heidelberg
    Heildelberg, 69126, Germany
  • Abteilung fur Pneumologie
    Hemer, 58675, Germany
  • Klinikum Nurnberg
    Nurnberg, 90419, Germany
  • Mater Misericordiae University Hospital
    Dublin, 7, Ireland
08

References and documents

Publications

  • Herth FJ, Ernst A, Baker KM, Egan JJ, Gotfried MH, Hopkins P, Stanzel F, Valipour A, Wagner M, Witt C, Kesten S, Snell G. Characterization of outcomes 1 year after endoscopic thermal vapor ablation for patients with heterogeneous emphysema. Int J Chron Obstruct Pulmon Dis. 2012;7:397-405. doi: 10.2147/COPD.S31082. Epub 2012 Jul 18. PubMed 22927751 ↗
  • Snell G, Herth FJ, Hopkins P, Baker KM, Witt C, Gotfried MH, Valipour A, Wagner M, Stanzel F, Egan JJ, Kesten S, Ernst A. Bronchoscopic thermal vapour ablation therapy in the management of heterogeneous emphysema. Eur Respir J. 2012 Jun;39(6):1326-33. doi: 10.1183/09031936.00092411. Epub 2011 Nov 10. PubMed 22075481 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01102712
Lead sponsor
Uptake Medical Corp
Responsible party
Sponsor
First posted
Apr 13, 2010
Start date
Nov 2009
Primary completion
Dec 2010
Completion
Aug 2011
Last update
Feb 23, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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