Actively Recruiting
Post-Market BTVA Registry
Led by Uptake Medical Technology, Inc. · Updated on 2025-01-28
300
Participants Needed
20
Research Sites
662 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-Market BTVA Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have heterogeneous emphysema confirmed by CT scan showing a heterogeneity index of 1.2 or greater in at least one lung segment to be treated
- Patients must be 18 years of age or older
- Patients must provide informed consent before joining the registry
You will not qualify if you...
- Forced expiratory volume in 1 second (FEV1) less than 20% of predicted
- Diffusing capacity for carbon monoxide (DLCO) less than 20% of predicted
- Unable to walk more than 140 meters in six minutes after optimized medical management
- Unstable COPD including any of the following: more than 3 COPD hospitalizations requiring antibiotics in past 12 months, COPD hospitalization in past 3 months, or daily use of systemic steroids above 5 mg prednisolone
- Significant other illnesses or medications that increase risk after treatment, including immune system disorders, relevant immunosuppressant use, bleeding disorders, unstable heart conditions, history of asthma or alpha-1 antitrypsin deficiency
- Newly prescribed morphine derivatives within last 4 weeks
- Pregnant or breastfeeding
- Highly diseased lower lung lobes with tissue to air ratio under 11%
- Active bacterial infection or symptoms like fever or high white blood cell count
- Presence of a single large bulla occupying more than one-third of a lung lobe or paraseptal emphysema in treated lobe
- Recent respiratory infection or COPD flare-up within the past 6 weeks
AI-Screening
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Trial Site Locations
Total: 20 locations
1
Krankenhaus Nord - Klinik Floridsdorf
Vienna, Austria, 1210
Actively Recruiting
2
Sozialstiftung Bamberg, Klinikum am Bruderwald
Bamberg, Germany, 96049
Actively Recruiting
3
DRK Kliniken Berlin / Mitte
Berlin, Germany, 13359
Actively Recruiting
4
FORSCHUNGSINSTITUT Havelhöhe gGmbH
Berlin, Germany, 14089
Actively Recruiting
5
Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, Germany, 45147
Actively Recruiting
6
Asklepios Fachkliniken München-Gauting
Gauting, Germany, 82131
Actively Recruiting
7
Martin-Luther-Universität Halle-Wittenberg (Saale)
Halle, Germany, 06120
Actively Recruiting
8
Thoraxklinik Heidelberg
Heidelberg, Germany, 69126
Actively Recruiting
9
Lungenklinik Hemer
Hemer, Germany, 58675
Actively Recruiting
10
Lungenfachklinik Immenhausen
Immenhausen, Germany, 34376
Actively Recruiting
11
Krankenhaus Martha-Maria München
München, Germany, 81479
Not Yet Recruiting
12
Klinikum Nürnberg Nord
Nuremberg, Germany, 90419
Actively Recruiting
13
Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH
Stuttgart, Germany, 70372
Actively Recruiting
14
Klinik Schillerhöhe
Stuttgart, Germany, 70376
Actively Recruiting
15
Kantonsspital Aarau AG
Aarau, Switzerland, 5001
Actively Recruiting
16
University Hospital Basel
Basel, Switzerland, 4031
Not Yet Recruiting
17
Lungen-und Schlafzentrum am Lindenhofspital AG, Bern
Bern, Switzerland, 3012
Actively Recruiting
18
Kantonsspital St.Gallen
Sankt Gallen, Switzerland, 9000
Withdrawn
19
LungenZentrum Hirslanden
Zurich, Switzerland, 8032
Actively Recruiting
20
Universitäts Spital Zürich
Zurich, Switzerland, 8091
Actively Recruiting
Research Team
J
Jennifer Idris
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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