Post-Market BTVA Registry

Launched by UPTAKE MEDICAL TECHNOLOGY, INC. · Oct 18, 2017

Keywords

ClinConnect Summary

The Post-Market BTVA Registry is studying a treatment called bronchoscopic thermal vapor ablation, which uses a special system to help patients with a type of lung disease called heterogeneous upper lobe emphysema. This trial aims to understand how this treatment affects patients’ quality of life over a five-year period. Researchers will gather information about patients' health, breathing ability, and how well they can exercise after receiving the treatment.

To be eligible for this study, patients need to be at least 18 years old and have a specific type of emphysema that shows a certain level of severity on a lung scan. However, those with very severe lung function, recent serious health issues, or certain other medical conditions cannot participate. If someone joins the study, they will receive the InterVapor treatment and will be followed closely to monitor their health and quality of life. This research will help us understand how effective this treatment is in everyday settings.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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
• • 2. Patients must be \> or equal to 18 years of age
• • 3. Patients are required to provide informed consent prior to inclusion in the Registry
• Exclusion Criteria:
• • 1. FEV1 \< 20% predicted
• • 2. DLCO \< 20% predicted
• • 3. Inability to walk \> 140 meters in 6 minutes (6MWD) following optimized medical management
• 4. Unstable COPD (any of the following):
• • 1. \> 3 COPD related hospitalizations requiring antibiotics in past 12 months
• • 2. COPD related hospitalization in past 3 months
• • 3. daily use of systemic steroids, i.e. \> 5 mg prednisolone
• • 5. 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
• • 6. Newly prescribed morphine derivatives within the last 4 weeks
• • 7. Pregnant or breastfeeding
• • 8. Highly diseased lower lobes (tissue to air ratio of \<11%)
• • 9. Bacterial infection or symptoms indicative of active infection (i.e., fever, elevated white blood cell count)
• • 10. Presence of single large bulla (defined as \> 1/3 volume of lobe) or a paraseptal distribution of emphysema in the treated lobe
• • 11. Recent respiratory infections or COPD exacerbation in preceding 6 weeks -