Post-Market BTVA Registry

Официальное название

Post-Market Registry for Patients With Emphysema Treated With BTVA

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Bronchoscopic Thermal Vapor Ablation
  Bronchoscopic vapor delivery to airway segment(s) targeted for treatment

Первичные конечные точки

• Change in Quality of Life [Срок оценки: Baseline to 24 months]

Вторичные конечные точки (8)

• Serious Adverse Events [Срок оценки: 6 and 12 months]
• Change in FEV1 [Срок оценки: Baseline to 12 months]
• Change in FVC [Срок оценки: Baseline to 12 months]
• Change in TLC [Срок оценки: Baseline to 12 months]
• Change in RV [Срок оценки: Baseline to 12 months]
• Change in DLCO [Срок оценки: Baseline to 12 months]
• Exercise Tolerance [Срок оценки: Baseline to 12 months]
• Lung volume reduction [Срок оценки: Baseline to 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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 -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 13 центров

• Sozialstiftung Bamberg, Klinikum am Bruderwald — Bamberg
• DRK Kliniken Berlin / Mitte — Berlin
• FORSCHUNGSINSTITUT Havelhöhe gGmbH — Berlin
• Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH — Essen
• Asklepios Fachkliniken München-Gauting — Gauting
• Martin-Luther-Universität Halle-Wittenberg (Saale) — Halle
• Thoraxklinik Heidelberg — Heidelberg
• Lungenklinik Hemer — Hemer
• … и ещё 5 центров

Швейцария · 6 центров

• Kantonsspital Aarau AG — Aarau
• University Hospital Basel — Basel
• Lungen-und Schlafzentrum am Lindenhofspital AG, Bern — Bern
• Kantonsspital St.Gallen — Sankt Gallen
• LungenZentrum Hirslanden — Zurich
• Universitäts Spital Zürich — Zurich

Австрия · 1 центр

• Krankenhaus Nord - Klinik Floridsdorf — Vienna

Идентификаторы

NCT: NCT03318406 · CSP-2410

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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