Actively Recruiting
Post-Market Registry for Patients With Emphysema Treated With Bronchoscopic Thermal Vapor Ablation Using InterVapor System
Led by Uptake Medical Technology, Inc. · Updated on 2025-01-28
300
Participants Needed
20
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of Bronchoscopic Thermal Vapor Ablation (BTVA) using Uptake Medical Technology Inc.'s InterVapor System for patients with heterogeneous upper lobe emphysema. This observational registry aims to understand the long-term impact of BTVA treatment on quality of life and other health measures in real-world clinical settings. Patients treated with InterVapor will be monitored to gather data on safety and effectiveness without a specific hypothesis about outcomes. The study will enroll up to 300 patients from sites in the EU and other select regions who have upper lobe predominant emphysema and are prescribed BTVA. After treatment with the InterVapor device, patients will be followed according to standard care practices for five years. Data collected will include lung function tests, exercise capacity, imaging results, and quality of life questionnaires. The registry also records all adverse events and has an independent monitor to assess serious event relatedness. Participants will undergo routine assessments including spirometry, body plethysmography, diffusing capacity for carbon monoxide, six-minute walk tests, chest X-rays, and CT scans. Quality of life will be tracked using a questionnaire over the five-year follow-up. Safety data and lung volume changes will be reviewed regularly. The study will summarize these data using descriptive statistics to provide a comprehensive picture of patient outcomes after BTVA treatment.
CONDITIONS
Brief Title
Post-Market BTVA Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with heterogeneous emphysema confirmed by high-resolution CT showing a heterogeneity index of 1.2 or higher in at least one lung segment
- Patients aged 18 years 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% predicted
- Diffusing capacity of the lung for carbon monoxide (DLCO) less than 20% predicted
- Unable to walk more than 140 meters in 6 minutes after optimized medical treatment
- Unstable COPD, including more than 3 COPD-related hospitalizations requiring antibiotics in the past year, a COPD hospitalization in the past 3 months, or daily use of systemic steroids over 5 mg prednisolone
- Other illnesses or medications that increase risk after treatment, such as immune disorders, bleeding problems, unstable heart conditions, asthma, or alpha-1 antitrypsin deficiency
- Newly prescribed morphine derivatives within the last 4 weeks
- Pregnant or breastfeeding
- Severely diseased lower lobes with tissue to air ratio below 11%
- Signs of bacterial infection or active infection symptoms like fever or high white blood cell count
- Presence of a single large bulla occupying more than one-third of the lung lobe volume or paraseptal emphysema in the treated lobe
- Recent respiratory infections or COPD exacerbation within the past 6 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of treatment
Participants undergo Bronchoscopic Thermal Vapor Ablation treatment using the InterVapor System.
1 treatment visit (in-person)
Duration - Up to 5 years
Participants are followed for up to five years after treatment with regular assessments including pulmonary function tests, exercise capacity tests, imaging, and quality of life questionnaires to monitor safety and effectiveness.
Scheduled follow-up visits as per routine care over 5 years
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
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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