NCT03318406Recruiting
Post-Market BTVA Registry
Post-Market Registry for Patients With Emphysema Treated With BTVA
Source: ClinicalTrials.gov · Last updated 28 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 13 Oct 2017
- Start date
- 22 Mar 2018
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Uptake Medical Technology, Inc.
- Diseases
- COPD
- NCT number
- NCT03318406
What you commit to
- Study type: Observational
- Planned participants: 300
- From 22 Mar 2018 to the primary completion date, 1 Dec 2027
- 20 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Recent respiratory infections or COPD exacerbation in preceding 6 weeks -
Lab values
- Bacterial infection or symptoms indicative of active infection (i.e., fever, elevated white blood cell count)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Krankenhaus Nord - Klinik Floridsdorf Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Kantonsspital Aarau AG Coordinator of this site? Confirm its status | Aarau | Switzerland | Recruiting |
| University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Not yet recruiting |
| Lungen-und Schlafzentrum am Lindenhofspital AG, Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| Kantonsspital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Withdrawn |
| LungenZentrum Hirslanden Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| Universitäts Spital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| Sozialstiftung Bamberg Klinikum am Bruderwald Coordinator of this site? Confirm its status | Bamberg | Germany | Recruiting |
| FORSCHUNGSINSTITUT Havelhöhe gGmbH Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| DRK Kliniken Berlin Mitte Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Asklepios Fachkliniken München-Gauting Coordinator of this site? Confirm its status | Gauting | Germany | Recruiting |
| Martin-Luther-Universität Halle-Wittenberg (Saale) Coordinator of this site? Confirm its status | Halle | Germany | Recruiting |
| Thoraxklinik Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Lungenklinik Hemer Coordinator of this site? Confirm its status | Hemer | Germany | Recruiting |
| Lungenfachklinik Immenhausen Coordinator of this site? Confirm its status | Immenhausen | Germany | Recruiting |
| Krankenhaus Martha-Maria München Coordinator of this site? Confirm its status | München | Germany | Not yet recruiting |
| Klinikum Nürnberg Nord Coordinator of this site? Confirm its status | Nuremberg | Germany | Recruiting |
| Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH Coordinator of this site? Confirm its status | Stuttgart | Germany | Recruiting |
| Klinik Schillerhöhe Coordinator of this site? Confirm its status | Stuttgart | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.