Emphysema or COPDNCT03318406
Post-Market BTVA Registry
An observational study of Emphysema or COPD, run by Uptake Medical Technology, Inc. at 20 sites in 3 countries.
Trial summary
Bronchoscopic thermal vapor ablation using Uptake Medical Technology Inc.'s InterVapor System is indicated for treatment of patients with heterogeneous upper lobe emphysema. This study is a retrospective and prospective, observational, multi-center, post-market registry of patients prescribed InterVapor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emphysema or COPD
- What is being tested?
- Bronchoscopic Thermal Vapor Ablation
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 22 Mar 2018to 1 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with upper lobe predominant emphysema being evaluated for possible InterVapor treatment will be considered for enrollment in the Registry
Who may be able to join
- Patients will have heterogeneous emphysema, as evidenced by high-resolution computed tomography (HRCT) demonstrating a heterogeneity index > or equal to 1.2 in at least one segment to be treated
- Patients must be > or equal to 18 years of age
- Patients are required to provide informed consent prior to inclusion in the Registry
Who cannot join
- FEV1 < 20% predicted
- DLCO < 20% predicted
- Inability to walk > 140 meters in 6 minutes (6MWD) following optimized medical management
- Unstable COPD (any of the following):
- > 3 COPD related hospitalizations requiring antibiotics in past 12 months
- COPD related hospitalization in past 3 months
Show all 14Show fewer
- daily use of systemic steroids, i.e. > 5 mg prednisolone
- Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with InterVapor. Examples of particular relevance include: immune system disorders, immunosuppressant medications of clinical relevance, bleeding disorders and unstable cardiovascular conditions, history of asthma or alpha-1 antitrypsin deficiency
- Newly prescribed morphine derivatives within the last 4 weeks
- Pregnant or breastfeeding
- Highly diseased lower lobes (tissue to air ratio of <11%)
- Bacterial infection or symptoms indicative of active infection (i.e., fever, elevated white blood cell count)
- Presence of single large bulla (defined as > 1/3 volume of lobe) or a paraseptal distribution of emphysema in the treated lobe
- Recent respiratory infections or COPD exacerbation in preceding 6 weeks -
Trial locations and contacts
20 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 3 countries
Germany13 sites, 13 recruiting
- Recruiting
Sozialstiftung Bamberg, Klinikum am Bruderwald
Bamberg, 96049
Beate Klaus
Wolfgang Hohenforst-Schmidt, MD
- Recruiting
DRK Kliniken Berlin / Mitte
Berlin, 13359
Jeanette Natschke, j.natschke@drk-kliniken-berlin.de
Bernd Schmidt, MD
- Recruiting
FORSCHUNGSINSTITUT Havelhöhe gGmbH
Berlin, 14089
Claudia Leichnitz, Claudia.leichnitz@havelhohe.de
Christian Grah, MD
- Recruiting
Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45147
Birte Schwarz, birte.schwarz@uk-essen.de
Kaid Darwiche, MD
- Recruiting
Asklepios Fachkliniken München-Gauting
Gauting, 82131
Rosalie Untsch, ro.untsch@asklepios.com
Wolfgang Gesierich, MD
- Recruiting
Martin-Luther-Universität Halle-Wittenberg (Saale)
Halle, 06120
Susanne Behl, susanne.behl@uk-halle.de
Stephan Eisenmann, MD
- Recruiting
Thoraxklinik Heidelberg
Heidelberg, 69126
Michaela Korthoeber, michaela.korthoeber@med.uni-heidelberg.de
Felix Herth, MD, PhD
- Recruiting
Lungenklinik Hemer
Hemer, 58675
Anja Schmidt, Anja.Schmidt@lkhemer.de
Franz Stanzel, MD
- Recruiting
Lungenfachklinik Immenhausen
Immenhausen, 34376
Katrin Schwedler, k.schwedler@lungenfachklinik-immenhausen.de
Peter Hammerl, MD
- Not yet recruiting
Krankenhaus Martha-Maria München
München, 81479
Andreas Fertl, MD
- Recruiting
Klinikum Nürnberg Nord
Nuremberg, 90419
Tanja Goetz, tanja.goetz@klinikum-nuernberg.de
Joachim Ficker, MD
- Recruiting
Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH
Stuttgart, 70372
Ute Höß, ute.hoess@sana.de
Martin Hetzel, MD
- Recruiting
Klinik Schillerhöhe
Stuttgart, 70376
Nina Lutz, nina.lutz@rbk.de
Claus Neurohr, MD
Switzerland6 sites, 5 recruiting
- Recruiting
Kantonsspital Aarau AG
Aarau, 5001
Sarosh Irani, MD
- Not yet recruiting
University Hospital Basel
Basel, 4031
Sandra Kunze, Sandra.Kunze@usb.ch
Michael Tamm, MD
- Recruiting
Lungen-und Schlafzentrum am Lindenhofspital AG, Bern
Bern, 3012
Tina Lauper, tina.lauper@pneumo-lindenhof.ch
Kaspar Remund, MD
- Withdrawn
Kantonsspital St.Gallen
Sankt Gallen, 9000
- Recruiting
LungenZentrum Hirslanden
Zurich, 8032
Karl Klingler, MD
- Recruiting
Universitäts Spital Zürich
Zurich, 8091
Christa Bodmer, Christa.Bodmer@usz.ch
Daniel Franzen, MD
Austria1 site, 1 recruiting
- Recruiting
Krankenhaus Nord - Klinik Floridsdorf
Vienna, 1210
Welz Kelly, kelly.welz@extern.gesundheitsverbund.at
Arschang Valipour, MD
About this study
Official title: Post-Market Registry for Patients With Emphysema Treated With BTVA
Bronchoscopic thermal vapor ablation using Uptake Medical Technology Inc.'s InterVapor System is indicated for treatment of patients with heterogeneous upper lobe emphysema. This study is a retrospective and prospective, observational, multi-center, post-market registry of patients prescribed InterVapor. The primary objective of the Registry is to describe the long-term impact of InterVapor treatment on patient quality of life (QOL) in a real-world setting. After InterVapor treatment, patients will be followed for 5 years as per the standard of care and safety and efficacy data (quality of life, pulmonary function, exercise capacity) collected as part of the registry.
Read the detailed description
The BTVA Registry will enroll up to 300 patients with upper lobe predominant emphysema that are being treated with BTVA at sites located in the EU and other select geographies. Patients will be followed as per standard of care and the registry will collect follow-up data for five years following treatment. The follow up data collected will include pulmonary function measurements (spirometry, body plethysmography, and diffusing capacity for carbon monoxide), exercise capacity (six minute walk test), imaging findings (chest x-ray and CT), and a quality of life questionnaire (SGRQ-C). All serious and non-serious adverse events will also be collected for the duration of the study in order to assess safety. Serious adverse events will be adjudicated by an independent medical monitor in order to establish relatedness to the InterVapor device and procedure.
Descriptive statistics will be used to summarize all safety and effectiveness data. There is no predefined hypothesis regarding the magnitude of effectiveness of InterVapor or the incidence of specific safety outcomes.
Monitoring of the registry study will be undertaken as a continuous process to ensure that high-quality data are obtained and to ensure compliance with registry procedures.
- Conditions
- Emphysema or COPD
- Being tested
- Bronchoscopic Thermal Vapor Ablation
- Keywords
- registry, vapor ablation, InterVapor, 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.
Bronchoscopic Thermal Vapor AblationDevice
Also called BTVA, InterVapor
Bronchoscopic vapor delivery to airway segment(s) targeted for treatment
| Study group | Role | What they receive |
|---|---|---|
| BTVA treated patients | Patients with heterogeneous upper lobe emphysema undergoing Bronchoscopic Thermal Vapor Ablation treatment Receives: Device: Bronchoscopic Thermal Vapor Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life
Change in Quality of Life score as assessed by the SGRQ-C questionnaire
Measured: Baseline to 24 months
Secondary outcomes (8)
Serious Adverse Events
procedure and device related serious adverse events, major medical complications
Measured: 6 and 12 months
Change in FEV1
Change in Forced Expired Volume in 1 second
Measured: Baseline to 12 months
Change in FVC
Change in Forced Vital Capacity
Measured: Baseline to 12 months
Change in TLC
Change in Total Lung Capacity
Measured: Baseline to 12 months
Change in RV
Change in Residual Volume
Measured: Baseline to 12 months
Change in DLCO
Change in Diffusing capacity of the lung for carbon monoxide
Measured: Baseline to 12 months
Exercise Tolerance
Change in six minute walk distance
Measured: Baseline to 12 months
Lung volume reduction
change in lung volume assessed by CT
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start22 Mar 2018
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emphysema or COPDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Uptake Medical Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felix Herth, MD, PhD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318406
- Sponsor's protocol ID
- CSP-2410
- Status last verified
- Jan 2025
- First submitted
- 13 Oct 2017
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Registry for Patients With Emphysema Treated With BTVA
- ClinicalTrials.gov ID
- NCT03318406
- Acronym / sponsor ID
- CSP-2410
- Conditions
- Emphysema or COPD
- Keywords
- registry, vapor ablation, InterVapor, BTVA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Uptake Medical Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 23 Oct 2017 (actual)
- 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.
Bronchoscopic thermal vapor ablation using Uptake Medical Technology Inc.'s InterVapor System is indicated for treatment of patients with heterogeneous upper lobe emphysema. This study is a retrospective and prospective, observational, multi-center, post-market registry of patients prescribed InterVapor. The primary objective of the Registry is to describe the long-term impact of InterVapor treatment on patient quality of life (QOL) in a real-world setting. After InterVapor treatment, patients will be followed for 5 years as per the standard of care and safety and efficacy data (quality of life, pulmonary function, exercise capacity) collected as part of the registry.
Detailed description
The BTVA Registry will enroll up to 300 patients with upper lobe predominant emphysema that are being treated with BTVA at sites located in the EU and other select geographies. Patients will be followed as per standard of care and the registry will collect follow-up data for five years following treatment. The follow up data collected will include pulmonary function measurements (spirometry, body plethysmography, and diffusing capacity for carbon monoxide), exercise capacity (six minute walk test), imaging findings (chest x-ray and CT), and a quality of life questionnaire (SGRQ-C). All serious and non-serious adverse events will also be collected for the duration of the study in order to assess safety. Serious adverse events will be adjudicated by an independent medical monitor in order to establish relatedness to the InterVapor device and procedure.
Descriptive statistics will be used to summarize all safety and effectiveness data. There is no predefined hypothesis regarding the magnitude of effectiveness of InterVapor or the incidence of specific safety outcomes.
Monitoring of the registry study will be undertaken as a continuous process to ensure that high-quality data are obtained and to ensure compliance with registry procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BTVA treated patients | – | Device: Bronchoscopic Thermal Vapor AblationPatients with heterogeneous upper lobe emphysema undergoing Bronchoscopic Thermal Vapor Ablation treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with upper lobe predominant emphysema being evaluated for possible InterVapor treatment will be considered for enrollment in the Registry
Key inclusion criteria (3 listed)
- Patients will have heterogeneous emphysema, as evidenced by high-resolution computed tomography (HRCT) demonstrating a heterogeneity index > or equal to 1.2 in at least one segment to be treated
- Patients must be > or equal to 18 years of age
- Patients are required to provide informed consent prior to inclusion in the Registry
Key exclusion criteria (14 listed)
- FEV1 < 20% predicted
- DLCO < 20% predicted
- Inability to walk > 140 meters in 6 minutes (6MWD) following optimized medical management
- Unstable COPD (any of the following):
- Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with InterVapor. Examples of particular relevance include: immune system disorders, immunosuppressant medications of clinical relevance, bleeding disorders and unstable cardiovascular conditions, history of asthma or alpha-1 antitrypsin deficiency
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 |
|---|---|---|
| Bronchoscopic Thermal Vapor AblationAlso: BTVA, InterVaporBronchoscopic vapor delivery to airway segment(s) targeted for treatment | Device | BTVA treated patients |
Primary outcome
Change in Quality of Life
Time frame: Baseline to 24 months
Change in Quality of Life score as assessed by the SGRQ-C questionnaire
8 secondary outcomes
Serious Adverse Events
Time frame: 6 and 12 months
Change in FEV1
Time frame: Baseline to 12 months
Change in FVC
Time frame: Baseline to 12 months
Change in TLC
Time frame: Baseline to 12 months
Change in RV
Time frame: Baseline to 12 months
Change in DLCO
Time frame: Baseline to 12 months
Exercise Tolerance
Time frame: Baseline to 12 months
Lung volume reduction
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Felix Herth, MD, PhD principal investigator
Heidelberg University
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emphysema or COPD, run by Uptake Medical Technology, Inc. at 20 sites in 3 countries.
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 3 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, Switzerland, Austria. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Idris (+1-408-391-0098, jidris@broncus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (time frame: Baseline to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2025.