Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Uptake Medical Corp
ClinicalTrials.gov Identifier:
NCT01041586
First received: December 22, 2009
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Emphysema
Chronic Obstructive Pulmonary Disease
Device: BTVA System
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Uptake Medical Corp:

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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: December 2009
Study Completion Date: August 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BTVA Device: BTVA System
Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041586

Locations
United States, Arizona
John C. Lincoln Hospital
Phoenix, Arizona, United States
United States, Iowa
University of Iowa
Iowa City, Iowa, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Washington
Swedish Hospital
Seattle, Washington, United States
Sponsors and Collaborators
Uptake Medical Corp
  More Information

No publications provided by Uptake Medical Corp

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Uptake Medical Corp
ClinicalTrials.gov Identifier: NCT01041586     History of Changes
Other Study ID Numbers: VAPOR-US
Study First Received: December 22, 2009
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Uptake Medical Corp:
Emphysema
COPD
Lung Volume Reduction
BTVA

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014