Registry for patients treated with bronchoscopic thermal vapor ablation for emphysema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Felix Herth, MD, PhD — Heidelberg University
• Study coordinator: Jennifer Idris
• Email: jidris@broncus.com
• Phone: +1-408-391-0098

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.