Post-Market BTVA Registry
Key facts
- Where
- Bamberg, Berlin, Essen, Gauting, Halle, Heidelberg, Hemer, Immenhausen, München, Nuremberg, and Stuttgart, GermanySee the 13 sites
Where in Germany
- Sozialstiftung Bamberg Klinikum am BruderwaldBamberg, GermanyTaking people
- DRK Kliniken Berlin MitteBerlin, GermanyTaking people
- FORSCHUNGSINSTITUT Havelhöhe gGmbHBerlin, GermanyTaking people
- Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbHEssen, GermanyTaking people
- Asklepios Fachkliniken München-GautingGauting, GermanyTaking people
- Martin-Luther-Universität Halle-Wittenberg (Saale)Halle, GermanyTaking people
- Thoraxklinik HeidelbergHeidelberg, GermanyTaking people
- Lungenklinik HemerHemer, GermanyTaking people
- Lungenfachklinik ImmenhausenImmenhausen, GermanyTaking people
- Krankenhaus Martha-Maria MünchenMünchen, GermanyNot yet recruiting
- Klinikum Nürnberg NordNuremberg, GermanyTaking people
- Klinik SchillerhöheStuttgart, GermanyTaking people
- Krankenhaus vom Roten Kreuz Bad Cannstatt GmbHStuttgart, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Uptake Medical Technology, Inc.
- Trial code
- NCT03318406
- Record updated
- 28 January 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; Recent respiratory infections or COPD exacerbation in preceding 6 weeks -; Bacterial infection or symptoms indicative of active infection (i.e., fever, elevated white blood cell count); FEV1 < 20% predicted; DLCO < 20% predicted; Inability to walk > 140 meters in 6 minutes (6MWD) following optimized medical management; Newly prescribed morphine derivatives within the last 4 weeks; Pregnant or breastfeeding; Highly diseased lower lobes (tissue to air ratio of <11%); Presence of single large bulla (defined as > 1/3 volume of lobe) or a paraseptal distribution of emphysema in the treated lobe.