Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGOBSERVATIONAL

Post-Market BTVA Registry

Post-Market Registry for Patients With Emphysema Treated With BTVA

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form prior to inclusion in the Registry Who Should NOT Join This Trial: 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 - Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 -

Treatments Being Tested

DEVICE

Bronchoscopic Thermal Vapor Ablation

Bronchoscopic vapor delivery to airway segment(s) targeted for treatment

Locations (20)

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
Lungenklinik Hemer
Hemer, Germany
Lungenfachklinik Immenhausen
Immenhausen, Germany
Krankenhaus Martha-Maria München
München, Germany
Klinikum Nürnberg Nord
Nuremberg, Germany
Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH
Stuttgart, Germany
Klinik Schillerhöhe
Stuttgart, Germany
Kantonsspital Aarau AG
Aarau, Switzerland
University Hospital Basel
Basel, Switzerland
Lungen-und Schlafzentrum am Lindenhofspital AG, Bern
Bern, Switzerland
Kantonsspital St.Gallen
Sankt Gallen, Switzerland
LungenZentrum Hirslanden
Zurich, Switzerland
Universitäts Spital Zürich
Zurich, Switzerland