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

Primary Purpose

Emphysema, Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BTVA System
Sponsored by
Uptake Medical Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema focused on measuring Emphysema, COPD, Lung Volume Reduction, BTVA

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; of pulmonary hypertension; indwelling pacemaker or implantable cardiac defibrillator (ICD); pregnancy or breastfeeding

Sites / Locations

  • John C. Lincoln Hospital
  • University of Iowa
  • Swedish Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BTVA

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Radiographic evidence of lung volume reduction (assessed by study site radiologist) and CT scan (assessed by blinded radiologist at CT core lab)

Full Information

First Posted
December 22, 2009
Last Updated
February 21, 2012
Sponsor
Uptake Medical Corp
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1. Study Identification

Unique Protocol Identification Number
NCT01041586
Brief Title
Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction
Acronym
BTVA
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uptake Medical Corp

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema, Chronic Obstructive Pulmonary Disease
Keywords
Emphysema, COPD, Lung Volume Reduction, BTVA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BTVA
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
BTVA System
Intervention Description
Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
John C. Lincoln Hospital
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Swedish Hospital
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22927751
Citation
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.
Results Reference
derived
PubMed Identifier
22075481
Citation
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.
Results Reference
derived

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Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

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