Status:
RECRUITING
Post-Market BTVA Registry
Lead Sponsor:
Uptake Medical Technology, Inc.
Conditions:
Emphysema or COPD
Eligibility:
All Genders
18+ years
Brief 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 retrospect...
Detailed Description
The BTVA Registry will enroll up to 300 patients with upper lobe predominant emphysema that are being treated with BTVA at sites located in the EU and other select geographies. Patients will be follow...
Eligibility Criteria
Inclusion
- 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
Exclusion
- FEV1 \< 20% predicted
- DLCO \< 20% predicted
- Inability to walk \> 140 meters in 6 minutes (6MWD) following optimized medical management
- 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
- Newly prescribed morphine derivatives within the last 4 weeks
- Pregnant or breastfeeding
- Highly diseased lower lobes (tissue to air ratio of \<11%)
- Bacterial infection or symptoms indicative of active infection (i.e., fever, elevated white blood cell count)
- Presence of single large bulla (defined as \> 1/3 volume of lobe) or a paraseptal distribution of emphysema in the treated lobe
- Recent respiratory infections or COPD exacerbation in preceding 6 weeks -
Key Trial Info
Start Date :
March 22 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03318406
Start Date
March 22 2018
End Date
December 1 2030
Last Update
January 28 2025
Active Locations (20)
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1
Krankenhaus Nord - Klinik Floridsdorf
Vienna, Austria, 1210
2
Sozialstiftung Bamberg, Klinikum am Bruderwald
Bamberg, Germany, 96049
3
DRK Kliniken Berlin / Mitte
Berlin, Germany, 13359
4
FORSCHUNGSINSTITUT Havelhöhe gGmbH
Berlin, Germany, 14089