NCT01102712

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2009

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

February 23, 2012

Status Verified

February 1, 2012

Enrollment Period

1.1 years

First QC Date

April 8, 2010

Last Update Submit

February 21, 2012

Conditions

EmphysemaChronic Obstructive Pulmonary Disease

Keywords

EmphysemaCOPDLung Volume ReductionBTVA

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (3)

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

    3 months

  • Changes in pulmonary function therapy

    3 months

  • Improvement in 6 minute walk distance

    3 months

Study Arms (1)

BTVA

EXPERIMENTAL
Device: BTVA System

Interventions

BTVA SystemDEVICE

Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction

BTVA

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3181, Australia

Location

LKH Klagenfurt

Klagenfurt, 9020, Austria

Location

Otto-Wagner Hospital

Vienna, 1140, Austria

Location

Zentralklinik Bad Berka

Bad Berka, 99437, Germany

Location

Charite Campus Mitte

Berlin, 10117, Germany

Location

Thoraxklinik Heidelberg

Heildelberg, 69126, Germany

Location

Abteilung fur Pneumologie

Hemer, 58675, Germany

Location

Klinikum Nurnberg

Nuremberg, 90419, Germany

Location

Mater Misericordiae University Hospital

Dublin, 7, Ireland

Location

Related Publications (2)

  • 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.

    PMID: 22927751DERIVED

  • 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.

    PMID: 22075481DERIVED

MeSH Terms

Conditions

EmphysemaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease Attributes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2010

First Posted

April 13, 2010

Study Start

November 1, 2009

Primary Completion

December 1, 2010

Study Completion

August 1, 2011

Last Updated

February 23, 2012

Record last verified: 2012-02

Locations

AU(2)IE(1)DE(5)