Post-Market BTVA Registry

Last updated: January 25, 2025
Sponsor: Uptake Medical Technology, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Emphysema

Treatment

Bronchoscopic Thermal Vapor Ablation

Clinical Study ID

NCT03318406
CSP-2410
  • Ages > 18
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients will have heterogeneous emphysema, as evidenced by high-resolution computedtomography (HRCT) demonstrating a heterogeneity index > or equal to 1.2 in at leastone segment to be treated

  2. Patients must be > or equal to 18 years of age

  3. Patients are required to provide informed consent prior to inclusion in the Registry

Exclusion

Exclusion Criteria:

  1. FEV1 < 20% predicted

  2. DLCO < 20% predicted

  3. Inability to walk > 140 meters in 6 minutes (6MWD) following optimized medicalmanagement

  4. Unstable COPD (any of the following):

  5. > 3 COPD related hospitalizations requiring antibiotics in past 12 months

  6. COPD related hospitalization in past 3 months

  7. daily use of systemic steroids, i.e. > 5 mg prednisolone

  8. Concomitant illnesses or medications that would pose a significant increased riskfor complications following treatment with InterVapor. Examples of particularrelevance include: immune system disorders, immunosuppressant medications ofclinical relevance, bleeding disorders and unstable cardiovascular conditions,history of asthma or alpha-1 antitrypsin deficiency

  9. Newly prescribed morphine derivatives within the last 4 weeks

  10. Pregnant or breastfeeding

  11. Highly diseased lower lobes (tissue to air ratio of <11%)

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

  13. Presence of single large bulla (defined as > 1/3 volume of lobe) or a paraseptaldistribution of emphysema in the treated lobe

  14. Recent respiratory infections or COPD exacerbation in preceding 6 weeks -

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Bronchoscopic Thermal Vapor Ablation
Phase:
Study Start date:
March 22, 2018
Estimated Completion Date:
December 01, 2030

Study 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.

Connect with a study center

  • Krankenhaus Nord - Klinik Floridsdorf

    Vienna, 1210
    Austria

    Active - Recruiting

  • Charles University

    Prague, 116 36
    Czechia

    Site Not Available

  • Sozialstiftung Bamberg, Klinikum am Bruderwald

    Bamberg, 96049
    Germany

    Active - Recruiting

  • Klinikum Bayreuth

    Bayreuth, 95445
    Germany

    Site Not Available

  • DRK Kliniken Berlin / Mitte

    Berlin, 13359
    Germany

    Active - Recruiting

  • FORSCHUNGSINSTITUT Havelhöhe gGmbH

    Berlin, 14089
    Germany

    Active - Recruiting

  • Fachkrankenhaus Coswig

    Coswig, 01640
    Germany

    Site Not Available

  • Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, 45147
    Germany

    Active - Recruiting

  • Asklepios Fachkliniken München-Gauting

    Gauting, 82131
    Germany

    Active - Recruiting

  • Klinik Shillerhöhe

    Gerlingen, 70839
    Germany

    Site Not Available

  • Martin-Luther-Universität Halle-Wittenberg (Saale)

    Halle, 06120
    Germany

    Active - Recruiting

  • Asklepios Klinikum Harburg

    Hamburg, 21075
    Germany

    Site Not Available

  • Thoraxklinik Heidelberg

    Heidelberg, 69126
    Germany

    Active - Recruiting

  • Lungenklinik Hemer

    Hemer, 58675
    Germany

    Active - Recruiting

  • St. Bernward Krankenhaus

    Hildesheim, 31134
    Germany

    Site Not Available

  • Sana Klinikum Hof

    Hof, 95032
    Germany

    Site Not Available

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376
    Germany

    Active - Recruiting

  • Krankenhaus Martha-Maria München

    München, 81479
    Germany

    Site Not Available

  • Ruppiner Kliniken

    Neuruppin, 16816
    Germany

    Site Not Available

  • Klinikum Nürnberg Nord

    Nürnberg, 90419
    Germany

    Active - Recruiting

  • Universitaetsmedizin Rostock

    Rostock, 18057
    Germany

    Site Not Available

  • Klinik Schillerhöhe

    Stuttgart, 70376
    Germany

    Active - Recruiting

  • Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH

    Stuttgart, 70372
    Germany

    Active - Recruiting

  • Mater Misericordiae

    Dublin, 7 D07R2WY
    Ireland

    Site Not Available

  • VU University Medical Center Amsterdam

    Amsterdam, 1981
    Netherlands

    Site Not Available

  • Kantonsspital Aarau AG

    Aarau, 5001
    Switzerland

    Active - Recruiting

  • University Hospital Basel

    Basel, 4031
    Switzerland

    Site Not Available

  • Lungen-und Schlafzentrum am Lindenhofspital AG, Bern

    Bern, 3012
    Switzerland

    Active - Recruiting

  • Luzerner Kantonsspital

    Luzern, 6000
    Switzerland

    Site Not Available

  • Kantonsspital St.Gallen

    St. Gallen, 9000
    Switzerland

    Site Not Available

  • LungenZentrum Hirslanden

    Zürich, 8032
    Switzerland

    Active - Recruiting

  • Universitäts Spital Zürich

    Zürich, 8091
    Switzerland

    Active - Recruiting

  • University College of London

    London, WC1E 6BT
    United Kingdom

    Site Not Available

  • Royal Preston Hospital

    Preston, PR2 9HT
    United Kingdom

    Site Not Available

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