Post-Market BTVA Registry

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 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 -

Conditions2

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