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NCT03318406Recruiting

Post-Market BTVA Registry

Post-Market Registry for Patients With Emphysema Treated With BTVA

Source: ClinicalTrials.gov · Last updated 28 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
13 Oct 2017
Start date
22 Mar 2018
Primary completion date
1 Dec 2027
Lead sponsor
Uptake Medical Technology, Inc.
Diseases
COPD
NCT number
NCT03318406

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 22 Mar 2018 to the primary completion date, 1 Dec 2027
  • 20 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Unstable COPD (any of the following):
    • \> 3 COPD related hospitalizations requiring antibiotics in past 12 months
    • COPD related hospitalization in past 3 months
    • 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

Other illness

  • Recent respiratory infections or COPD exacerbation in preceding 6 weeks -

Lab values

  • Bacterial infection or symptoms indicative of active infection (i.e., fever, elevated white blood cell count)

Other

  • FEV1 \< 20% predicted
  • DLCO \< 20% predicted
  • Inability to walk \> 140 meters in 6 minutes (6MWD) following optimized medical management
  • Newly prescribed morphine derivatives within the last 4 weeks
  • Pregnant or breastfeeding
  • Highly diseased lower lobes (tissue to air ratio of \<11%)
  • Presence of single large bulla (defined as \> 1/3 volume of lobe) or a paraseptal distribution of emphysema in the treated lobe

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Krankenhaus Nord - Klinik Floridsdorf
Coordinator of this site? Confirm its status
ViennaAustriaRecruiting
Kantonsspital Aarau AG
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AarauSwitzerlandRecruiting
University Hospital Basel
Coordinator of this site? Confirm its status
BaselSwitzerlandNot yet recruiting
Lungen-und Schlafzentrum am Lindenhofspital AG, Bern
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BernSwitzerlandRecruiting
Kantonsspital St. Gallen
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Sankt GallenSwitzerlandWithdrawn
LungenZentrum Hirslanden
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ZurichSwitzerlandRecruiting
Universitäts Spital Zürich
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ZurichSwitzerlandRecruiting
Sozialstiftung Bamberg Klinikum am Bruderwald
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BambergGermanyRecruiting
FORSCHUNGSINSTITUT Havelhöhe gGmbH
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BerlinGermanyRecruiting
DRK Kliniken Berlin Mitte
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BerlinGermanyRecruiting
Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
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EssenGermanyRecruiting
Asklepios Fachkliniken München-Gauting
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GautingGermanyRecruiting
Martin-Luther-Universität Halle-Wittenberg (Saale)
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HalleGermanyRecruiting
Thoraxklinik Heidelberg
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HeidelbergGermanyRecruiting
Lungenklinik Hemer
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HemerGermanyRecruiting
Lungenfachklinik Immenhausen
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ImmenhausenGermanyRecruiting
Krankenhaus Martha-Maria München
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MünchenGermanyNot yet recruiting
Klinikum Nürnberg Nord
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NurembergGermanyRecruiting
Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH
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StuttgartGermanyRecruiting
Klinik Schillerhöhe
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StuttgartGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.