Post-Market BTVA Registry

Recruiting now

Conditions studied: Emphysema or COPD

In brief

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.

Key facts

Study ID

NCT03318406

Run by

Uptake Medical Technology, Inc.

People needed

300

Starts

2018-03-22

Expected to finish

2030-12-01

Last updated by the study team

2025-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Patients must be > or equal to 18 years of age
• Patients are required to provide informed consent prior to inclusion in the Registry

You may not qualify if…

• FEV1 < 20% predicted
• DLCO < 20% predicted
• Inability to walk > 140 meters in 6 minutes (6MWD) following optimized medical management
• Unstable COPD (any of the following):
• > 3 COPD related hospitalizations requiring antibiotics in past 12 months
• COPD related hospitalization in past 3 months
• daily use of systemic steroids, i.e. > 5 mg prednisolone
• 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
• Newly prescribed morphine derivatives within the last 4 weeks
• Pregnant or breastfeeding
• Highly diseased lower lobes (tissue to air ratio of <11%)
• Bacterial infection or symptoms indicative of active infection (i.e., fever, elevated white blood cell count)
• Presence of single large bulla (defined as > 1/3 volume of lobe) or a paraseptal distribution of emphysema in the treated lobe
• Recent respiratory infections or COPD exacerbation in preceding 6 weeks -

Where it is running

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

Full record on ClinicalTrials.gov

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