Registry for patients treated with bronchoscopic thermal vapor ablation for emphysema

Post-Market Registry for Patients With Emphysema Treated With BTVA

This study is collecting information from up to 300 patients with upper lobe emphysema who are treated with a new vapor therapy to see how it affects their quality of life and lung function over five years.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Uptake Medical Technology, Inc. (industry)
• Locations: 20 sites (Vienna and 19 other locations)
• Trial ID: NCT03318406 on ClinicalTrials.gov

What this trial studies

This observational registry collects data on patients with heterogeneous upper lobe emphysema who are treated with the InterVapor System. It aims to evaluate the long-term impact of this treatment on patient quality of life, pulmonary function, and exercise capacity over a five-year follow-up period. The registry will enroll up to 300 patients across multiple centers in the EU and other select locations, gathering both retrospective and prospective data. Safety and efficacy will be monitored through various assessments, including spirometry and quality of life questionnaires.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with heterogeneous emphysema as confirmed by high-resolution CT scans.

Not a fit: Patients with severe lung function impairment or unstable COPD may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the long-term benefits of bronchoscopic thermal vapor ablation for improving the quality of life in emphysema patients.

How similar studies have performed: While this registry approach is observational, similar studies have shown promising results in evaluating long-term outcomes for patients undergoing innovative treatments for emphysema.

Eligibility criteria

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 -

Where this trial is running

Vienna and 19 other locations

• Krankenhaus Nord - Klinik Floridsdorf — Vienna, Austria (RECRUITING)
• Sozialstiftung Bamberg, Klinikum am Bruderwald — Bamberg, Germany (RECRUITING)
• DRK Kliniken Berlin / Mitte — Berlin, Germany (RECRUITING)
• FORSCHUNGSINSTITUT Havelhöhe gGmbH — Berlin, Germany (RECRUITING)
• Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH — Essen, Germany (RECRUITING)
• Asklepios Fachkliniken München-Gauting — Gauting, Germany (RECRUITING)
• Martin-Luther-Universität Halle-Wittenberg (Saale) — Halle, Germany (RECRUITING)
• Thoraxklinik Heidelberg — Heidelberg, Germany (RECRUITING)
• Lungenklinik Hemer — Hemer, Germany (RECRUITING)
• Lungenfachklinik Immenhausen — Immenhausen, Germany (RECRUITING)
• Krankenhaus Martha-Maria München — München, Germany (NOT_YET_RECRUITING)
• Klinikum Nürnberg Nord — Nuremberg, Germany (RECRUITING)
• Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH — Stuttgart, Germany (RECRUITING)
• Klinik Schillerhöhe — Stuttgart, Germany (RECRUITING)
• Kantonsspital Aarau AG — Aarau, Switzerland (RECRUITING)
• University Hospital Basel — Basel, Switzerland (NOT_YET_RECRUITING)
• Lungen-und Schlafzentrum am Lindenhofspital AG, Bern — Bern, Switzerland (RECRUITING)
• Kantonsspital St.Gallen — Sankt Gallen, Switzerland (WITHDRAWN)
• LungenZentrum Hirslanden — Zurich, Switzerland (RECRUITING)
• Universitäts Spital Zürich — Zurich, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Felix Herth, MD, PhD — Heidelberg University
• Study coordinator: Jennifer Idris

Conditions: Emphysema or COPD, registry, vapor ablation, InterVapor, BTVA