- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01041586
Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction (BTVA)
February 21, 2012 updated by: Uptake Medical Corp
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
To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous upper lobe emphysema.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States
- John C. Lincoln Hospital
-
-
Iowa
-
Iowa City, Iowa, United States
- University of Iowa
-
-
Massachusetts
-
Boston, Massachusetts, United States
-
-
Washington
-
Seattle, Washington, United States
- Swedish Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: BTVA
|
Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (ACTUAL)
January 1, 2011
Study Completion (ACTUAL)
August 1, 2011
Study Registration Dates
First Submitted
December 22, 2009
First Submitted That Met QC Criteria
December 30, 2009
First Posted (ESTIMATE)
December 31, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
February 23, 2012
Last Update Submitted That Met QC Criteria
February 21, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VAPOR-US
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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