EmphysemaPhase 1BTVANCT01041586
Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction
A Phase 1 study testing BTVA System in people with Emphysema and Chronic Obstructive Pulmonary Disease, run by Uptake Medical Corp at 4 sites in United States.
Trial summary
To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous upper lobe emphysema. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Emphysema, Chronic Obstructive Pulmonary Disease
- What is being tested?
- BTVA System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2009to Aug 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- mMRC ≥ 2 (mMRC)
- Non-smoking for 3 months
- Optimized medical management and completed pulmonary rehabilitation
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Boston, Massachusetts
University of Iowa
Iowa City, Iowa
John C. Lincoln Hospital
Phoenix, Arizona
Swedish Hospital
Seattle, Washington
About this study
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
To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous upper lobe emphysema.
Read the 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.
- Conditions
- Emphysema, Chronic Obstructive Pulmonary Disease
- Being tested
- BTVA System
- Keywords
- Emphysema, COPD, Lung Volume Reduction, BTVA
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTVA SystemDevice
Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction
| Study group | Role | What they receive |
|---|---|---|
| BTVA | Experimental | Not described Receives: Device: BTVA System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Radiographic evidence of lung volume reduction (assessed by study site radiologist) and CT scan (assessed by blinded radiologist at CT core lab)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJan 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uptake Medical Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041586
- Sponsor's protocol ID
- VAPOR-US
- Acronym
- BTVA
- Status last verified
- Feb 2012
- First submitted
- 22 Dec 2009
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
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 22927751Snell 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01041586
- Acronym / sponsor ID
- BTVA / VAPOR-US
- Conditions
- Emphysema, Chronic Obstructive Pulmonary Disease
- Keywords
- Emphysema, COPD, Lung Volume Reduction, BTVA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Uptake Medical CorpIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 31 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BTVA | Experimental | Device: BTVA System |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: > 40 and ≤ 75 years old
- Diagnosis of heterogeneous emphysema with upper lobe predominance
- FEV1 < 45% predicted
- TLC > 100% predicted
- RV > 150% predicted
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTVA SystemUnilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction | Device | BTVA |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2012.
- Derived from this study: PubMed 22927751Herth 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.
- Derived from this study: PubMed 22075481Snell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BTVA System in people with Emphysema and Chronic Obstructive Pulmonary Disease, run by Uptake Medical Corp at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01041586, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2012.