Post-Market BTVA Registry

January 25, 2025 updated by: Uptake Medical Technology, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
  • Germany
      • Bamberg, Germany, 96049
        • Recruiting
        • Sozialstiftung Bamberg, Klinikum am Bruderwald
        • Contact:
          • Beate Klaus
        • Contact:
          • Wolfgang Hohenforst-Schmidt, MD
      • Berlin, Germany, 13359
      • Berlin, Germany, 14089
      • Essen, Germany, 45147
        • Recruiting
        • Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
        • Contact:
        • Contact:
          • Kaid Darwiche, MD
      • Gauting, Germany, 82131
        • Recruiting
        • Asklepios Fachkliniken München-Gauting
        • Contact:
        • Contact:
          • Wolfgang Gesierich, MD
      • Halle, Germany, 06120
        • Recruiting
        • Martin-Luther-Universität Halle-Wittenberg (Saale)
        • Contact:
        • Contact:
          • Stephan Eisenmann, MD
      • Heidelberg, Germany, 69126
      • Hemer, Germany, 58675
      • Immenhausen, Germany, 34376
      • München, Germany, 81479
        • Not yet recruiting
        • Krankenhaus Martha-Maria München
        • Contact:
          • Andreas Fertl, MD
      • Nürnberg, Germany, 90419
      • Stuttgart, Germany, 70376
        • Recruiting
        • Klinik Schillerhöhe
        • Contact:
        • Contact:
          • Claus Neurohr, MD
      • Stuttgart, Germany, 70372
        • Recruiting
        • Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH
        • Contact:
        • Contact:
          • Martin Hetzel, MD
  • Switzerland
      • Aarau, Switzerland, 5001
        • Recruiting
        • Kantonsspital Aarau AG
        • Contact:
          • Sarosh Irani, MD
      • Basel, Switzerland, 4031
        • Not yet recruiting
        • University Hospital Basel
        • Contact:
        • Contact:
          • Michael Tamm, MD
      • Bern, Switzerland, 3012
      • St. Gallen, Switzerland, 9000
        • Withdrawn
        • Kantonsspital St.Gallen
      • Zürich, Switzerland, 8032
        • Recruiting
        • LungenZentrum Hirslanden
        • Contact:
          • Karl Klingler, MD
      • Zürich, Switzerland, 8091
        • Recruiting
        • Universitäts Spital Zürich
        • Contact:
        • Contact:
          • Daniel Franzen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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

Description

Inclusion Criteria:

  1. 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
  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 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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Quality of Life
Time Frame: Baseline to 24 months
Change in Quality of Life score as assessed by the SGRQ-C questionnaire
Baseline to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serious Adverse Events
Time Frame: 6 and 12 months
procedure and device related serious adverse events, major medical complications
6 and 12 months
Change in FEV1
Time Frame: Baseline to 12 months
Change in Forced Expired Volume in 1 second
Baseline to 12 months
Change in FVC
Time Frame: Baseline to 12 months
Change in Forced Vital Capacity
Baseline to 12 months
Change in TLC
Time Frame: Baseline to 12 months
Change in Total Lung Capacity
Baseline to 12 months
Change in RV
Time Frame: Baseline to 12 months
Change in Residual Volume
Baseline to 12 months
Change in DLCO
Time Frame: Baseline to 12 months
Change in Diffusing capacity of the lung for carbon monoxide
Baseline to 12 months
Exercise Tolerance
Time Frame: Baseline to 12 months
Change in six minute walk distance
Baseline to 12 months
Lung volume reduction
Time Frame: Baseline to 6 months
change in lung volume assessed by CT
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uptake Medical Technology, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Felix Herth, MD, PhD, Thoraxklinik University of Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSP-2410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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