Post-Market BTVA Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03318406
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : May 3, 2018
acromion GmbH
Information provided by (Responsible Party):
Uptake Medical Technology, Inc.

Brief 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.

Condition or disease Intervention/treatment
Emphysema or COPD Device: Bronchoscopic thermal vapor ablation

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 Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Post-Market BTVA Registry for Patients With Emphysema Treated With BTVA
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Group/Cohort Intervention/treatment
BTVA treated patients
Patients with heterogeneous upper lobe emphysema undergoing Bronchoscopic Thermal Vapor Ablation treatment
Device: Bronchoscopic thermal vapor ablation
Bronchoscopic vapor delivery to airway segment(s) targeted for treatment
Other Names:
  • BTVA
  • InterVapor

Primary Outcome Measures :
  1. Change in Quality of Life [ Time Frame: Baseline to 12 months ]
    Change in Quality of Life score as assessed by the SGRQ-C questionnaire

Secondary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: 6 and 12 months ]
    procedure and device related serious adverse events

  2. Change in FEV1 [ Time Frame: Baseline to 12 months ]
    Change in Forced Expired Volume in 1 second

  3. Change in RV [ Time Frame: Baseline to 12 months ]
    Change in Residual Volume

  4. Change in DLCO [ Time Frame: Baseline to 12 months ]
    Change in Diffusing capacity of the lung for carbon monoxide

  5. Exercise Tolerance [ Time Frame: Baseline to 12 months ]
    Change in six minute walk distance

  6. Lung volume reduction [ Time Frame: Baseline to 6 months ]
    change in lung volume assessed by CT

Other Outcome Measures:
  1. Change in FVC [ Time Frame: Baseline to 12 months ]
    Change in forced vital capacity

  2. Change in TLC [ Time Frame: Baseline 12 months ]
    Change in otal lung capacity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with upper lobe predominant emphysema being evaluated for possible InterVapor treatment will be considered for enrollment in the Registry

Inclusion Criteria:

  1. Patients will have heterogeneous emphysema, as evidenced by high-resolution computed tomography (HRCT) demonstrating a heterogeneity index >1.2 in at least one segment to be treated
  2. Patients must be > 18 years of age
  3. Patients are required to provide informed consent prior to inclusion in the Registry

Exclusion Criteria:

  1. FEV1 < 20% predicted
  2. DLCO < 20% predicted
  3. Inability to walk > 140 meters in 6 minutes (6MWD) following optimized medical management
  4. Unstable COPD (any of the following):

    1. > 3 COPD related hospitalizations requiring antibiotics in past 12 months
    2. COPD related hospitalization in past 3 months
    3. daily use of systemic steroids, i.e. > 5 mg prednisolone
  5. 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
  6. Newly prescribed morphine derivatives within the last 4 weeks
  7. Pregnant or breastfeeding
  8. Highly diseased lower lobes (tissue to air ratio of <11%)
  9. Bacterial infection or symptoms indicative of active infection (i.e., fever, elevated white blood cell count)
  10. Presence of single large bulla (defined as > 1/3 volume of lobe) or a paraseptal distribution of emphysema in the treated lobe
  11. Recent respiratory infections or COPD exacerbation in preceding 6 weeks -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03318406

Contact: Jordan Low 206 926-7408
Contact: Julie Arneson 206 926 7408

Otto-Wagner Hospital Not yet recruiting
Vienna, Austria
Contact: Marina Duller   
Principal Investigator: Arschang Valipour, MD         
Klinikum Bayreuth Not yet recruiting
Bayreuth, Germany, 95445
Principal Investigator: Claus Steppert, MD, MHBA         
Charite Mitte Not yet recruiting
Berlin, Germany, 10117
Principal Investigator: Christian Witt, MD         
Charite - Campus Virchow Klinikum Not yet recruiting
Berlin, Germany, 13352
Principal Investigator: Ralf-Harto Huebner, MD         
Gemeinschaftskrankenhaus Havelhöhe Recruiting
Berlin, Germany, 14089
Principal Investigator: Christian Grah, MD         
Fachkrankenhaus Coswig Not yet recruiting
Coswig, Germany, 01640
Principal Investigator: Dirk Koschel, MD         
Ruhrlandklinik - West German Lung Center Not yet recruiting
Essen, Germany, 45239
Principal Investigator: Kaid Darwiche, MD         
Asklepios Fachkliniken München-Gauting Not yet recruiting
Gauting, Germany, D-82131
Principal Investigator: Wolfgang Gesierich, MD         
Universitätsklinikum Halle (Saale) Not yet recruiting
Halle, Germany, 06120
Principal Investigator: Stephan Eisenmann, MD         
Asklepios Klinikum Harburg Not yet recruiting
Hamburg, Germany, 21075
Principal Investigator: Christoph Petermann, MD         
Thoraxklinik Heidelberg Recruiting
Heidelberg, Germany, 69126
Principal Investigator: Felix Herth, MD, PhD         
Sub-Investigator: Ralf Eberhardt, MD         
Sub-Investigator: Daniela Gompelmann, MD         
Lungenklinik Hemer Not yet recruiting
Hemer, Germany, 58675
Principal Investigator: Franz Stanzel, MD         
St. Bernward Krankenhaus Not yet recruiting
Hildesheim, Germany, 31134
Principal Investigator: Jürgen Heck, MD         
Lungenfachklinik Immenhausen Not yet recruiting
Immenhausen, Germany, 34376
Principal Investigator: Peter Hammerl, MD         
Ruppiner Kliniken Not yet recruiting
Neuruppin, Germany, 16816
Principal Investigator: Hagen Kelm, MD         
Klinikum Nürnberg Nord Not yet recruiting
Nürnberg, Germany, 90419
Principal Investigator: Manfred Wagner, MD         
Universitaetsmedizin Rostock Not yet recruiting
Rostock, Germany, 18057
Principal Investigator: Marek Lommatzsch, MD         
Krankenhaus vom Roten Kreuz Bad Cannstatt Not yet recruiting
Stuttgart, Germany, 70372
Principal Investigator: Martin Hetzel, MD         
Mater Misericordiae Not yet recruiting
Dublin, Ireland, 7 D07R2WY
Principal Investigator: Jim Egan, MD         
University Hospital Basel Not yet recruiting
Basel, Switzerland, 4031
Principal Investigator: Michael Tamm, MD         
Luzerner Kantonsspital Not yet recruiting
Luzern, Switzerland, 6000
Kantonsspital St.Gallen Not yet recruiting
St. Gallen, Switzerland, 9007
Sub-Investigator: Tino Schneider, MD         
Principal Investigator: Martin Brutsche, MD         
Sponsors and Collaborators
Uptake Medical Technology, Inc.
acromion GmbH
Principal Investigator: Felix Herth, MD, PhD Thoraxklinik University of Heidelberg

Responsible Party: Uptake Medical Technology, Inc. Identifier: NCT03318406     History of Changes
Other Study ID Numbers: CSP-2410
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Uptake Medical Technology, Inc.:
vapor ablation

Additional relevant MeSH terms:
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases