Post-Market BTVA Registry
Post-Market Registry for Patients With Emphysema Treated With BTVA
Uptake Medical Technology, Inc.
300 participants
Mar 22, 2018
OBSERVATIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria14
- 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 -
Interventions
Bronchoscopic vapor delivery to airway segment(s) targeted for treatment
Locations(20)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03318406