Post-Market BTVA Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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 followed as per standard of care and the registry will collect follow-up data for five years following treatment. The follow up data collected will include pulmonary function measurements (spirometry, body plethysmography, and diffusing capacity for carbon monoxide), exercise capacity (six minute walk test), imaging findings (chest x-ray and CT), and a quality of life questionnaire (SGRQ-C). All serious and non-serious adverse events will also be collected for the duration of the study in order to assess safety. Serious adverse events will be adjudicated by an independent medical monitor in order to establish relatedness to the InterVapor device and procedure. Descriptive statistics will be used to summarize all safety and effectiveness data. There is no predefined hypothesis regarding the magnitude of effectiveness of InterVapor or the incidence of specific safety outcomes. Monitoring of the registry study will be undertaken as a continuous process to ensure that high-quality data are obtained and to ensure compliance with registry procedures.

Official Title
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Post-Market Registry for Patients With Emphysema Treated With BTVA

Conditions
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Emphysema or COPD

Intervention / Treatment
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* Device: Bronchoscopic Thermal Vapor Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BTVA treated patients<br>Patients with heterogeneous upper lobe emphysema undergoing Bronchoscopic Thermal Vapor Ablation treatment | Device: Bronchoscopic Thermal Vapor Ablation<br>* Bronchoscopic vapor delivery to airway segment(s) targeted for treatment<br>* Other names: InterVapor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | Change in Quality of Life score as assessed by the SGRQ-C questionnaire | Baseline to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events | procedure and device related serious adverse events, major medical complications | 6 and 12 months | 
| Change in FEV1 | Change in Forced Expired Volume in 1 second | Baseline to 12 months | 
| Change in FVC | Change in Forced Vital Capacity | Baseline to 12 months | 
| Change in TLC | Change in Total Lung Capacity | Baseline to 12 months | 
| Change in RV | Change in Residual Volume | Baseline to 12 months | 
| Change in DLCO | Change in Diffusing capacity of the lung for carbon monoxide | Baseline to 12 months | 
| Exercise Tolerance | Change in six minute walk distance | Baseline to 12 months | 
| Lung volume reduction | change in lung volume assessed by CT | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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registry, vapor ablation, InterVapor, BTVA