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Clinical Trials in Austria / NCT03318406
Recruiting Observational

Post-Market BTVA Registry

NCT03318406 · tracked via the Priya Life Science Austria tracker
Sponsor
Uptake Medical Technology, Inc
Phase
Observational
Started
2018-03-22
Last updated
2025-01-28

Condition(s) studied

Emphysema or COPD

Investigational drug(s) / intervention(s)

Bronchoscopic Thermal Vapor Ablation

Bronchoscopic Thermal Vapor Ablation: Bronchoscopic vapor delivery to airway segment(s) targeted for treatment

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 -

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
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
Martin-Luther-Universität Halle-Wittenberg (Saale) Halle Germany Recruiting
Thoraxklinik Heidelberg Heidelberg Germany Recruiting
Lungenklinik Hemer Hemer Germany Recruiting
Lungenfachklinik Immenhausen Immenhausen Germany Recruiting
Krankenhaus Martha-Maria München München Germany Not Yet Recruiting
Klinikum Nürnberg Nord Nuremberg Germany Recruiting
Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH Stuttgart Germany Recruiting
Klinik Schillerhöhe Stuttgart Germany Recruiting
Kantonsspital Aarau AG Aarau Switzerland Recruiting
University Hospital Basel Basel Switzerland Not Yet Recruiting
Lungen-und Schlafzentrum am Lindenhofspital AG, Bern Bern Switzerland Recruiting
Kantonsspital St.Gallen Sankt Gallen Switzerland Withdrawn
LungenZentrum Hirslanden Zurich Switzerland Recruiting
Universitäts Spital Zürich Zurich Switzerland Recruiting

More Uptake Medical Technology, Inc. trials in Austria

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03318406 on ClinicalTrials.gov ↗ ← All trials in Austria