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Post-Market BTVA Registry

Recruitingn/aAges 18 Years - anyAllUptake Medical Technology, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 -
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What it tests

  • Bronchoscopic Thermal Vapor Ablation
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Where

20 sites
Krankenhaus Nord - Klinik Floridsdorf
Vienna, Austria
Sozialstiftung Bamberg, Klinikum am Bruderwald
Bamberg, Germany
DRK Kliniken Berlin / Mitte
Berlin, Germany
FORSCHUNGSINSTITUT Havelhöhe gGmbH
Berlin, Germany
Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, Germany
Asklepios Fachkliniken München-Gauting
Gauting, Germany
Martin-Luther-Universität Halle-Wittenberg (Saale)
Halle, Germany
Thoraxklinik Heidelberg
Heidelberg, Germany

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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