This study is a Prospective, single arm, single center pilot study following outcomes for 12 months after initial BTVA treatment. The primary objectives of the study are to prospectively document the safety and efficacy of sequential segmental treatment with BTVA in patients with a homogeneous distribution of emphysema that are not candidates for endobronchial valve therapy.
The study will include patients with severe emphysema as defined by pulmonary function tests, a homogeneous distribution of emphysema as determined by CT, who are not eligible for endobronchial valve therapy based on fissure integrity as determined by CT. Enrollment will continue until 10 patients have been treated per protocol or until a maximum of 15 patients total have been treated. Patients will be enrolled at Thoraxklinik University of Heidelberg, Germany and followed for twelve (12) months. The follow up data collected will include pulmonary function testing (spirometry, body plethysmography, DLCO), exercise capacity (six minute walk test) and imaging findings (chest x-ray and CT). Dyspnea score (mMRC) and quality of life questionnaire (SGRQ-C) information will be obtained. Information regarding adverse events, serious adverse events, and major medical complications will be collected at each visit. 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 efficacy data. There is no predefined hypothesis regarding safety, or efficacy. Monitoring of the study will be undertaken as a continuous process to ensure that high-quality data are obtained and to ensure compliance with study procedures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Bronchoscopic vapor delivery to airway segment(s) targeted for treatment
Thoraxklinik University of Heidelberg
Heidelberg, Germany
Incidence of SAEs, Major Medical complications, and unanticipated serious adverse device effects (USADEs) (safety endpoint)
Occurrence of SAEs, Major Medical complications, and unanticipated serious adverse device effects (USADEs) (safety endpoint)
Time frame: Baseline to 6 months
Change in FEV1 (efficacy endpoint)
Change in FEV1 (efficacy endpoint)
Time frame: Baseline to 6 months
Change in St Georges Respiratory Questionnaire for COPD Patients (SGRQ-C) score (efficacy endpoint)
This trial will utilize the SGRQ-C which is a shortened version of the SGRQ questionnaire. The SGRQ is a validated, disease-specific questionnaire that measures health-related quality of life in patients with COPD. The instrument has 3 domains (activity, symptoms, and impacts) and a total score. A Total and three-component scores are calculated: Symptoms; Activity; Impacts. Each questionnaire response has a unique empirically derived 'weight'. The lowest possible weight is zero and the highest is 100. Each component of the questionnaire is scored separately. Sum of maximum possible weights for each component and Total: Symptoms 566.2, Activity 982.9, Impacts 1652.8. Total (sum of maximum for all three components) 3201.9 Higher weights indicate worse outcomes. The difference in the domain scores and total score at follow-up visits relative to baseline will be calculated and reported.
Time frame: Baseline to 6 months
Change in FVC
Change in Forced Vital Capacity
Time frame: Baseline to 6 months
Change in FRC
Change in Forced Residual Capacity
Time frame: Baseline to 6 months
Change in RV
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Change in Residual Volume
Time frame: Baseline to 6 months
Change in TLC
Change in Total Lung Capacity
Time frame: Baseline to 6 months
Change in RV/TLC
Change in Residual Volume/Total Lung Capacity
Time frame: Baseline to 6 months
Change in DLCO
Change in Diffusing capacity of the lung for carbon monoxide
Time frame: Baseline to 6 months
Change in Modified Medical Research Council (mMRC) Dyspnea scale
Change in dyspnea score. Grade Degree of Breathlessness Related to Activities Grade 0 No breathlessness except with strenuous exercise Grade 1 Breathlessness when hurrying on the level or walking up a slight hill Grade 2 Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on the level Grade 3 Stops for breath after walking about 100 yards or a few minutes on the level Grade 4 Too breathless to leave the house or breathless when dressing or undressing Max score=4, Min score=0 One score is reported based on grade. Higher values represent worse outcomes. For patients with a higher mMRC grade (e.g. ≥2) and clinical circumstances consistent with respiratory disease, measuring spirometry (e.g., FEV₁ and FVC), determining the patient's GOLD stage, helps guide therapeutic interventions.
Time frame: Baseline to 6 months
Change in 6MWD
Change in six minute walk distance
Time frame: Baseline to 6 months
Change in volume of the treated lobe(s)
Change in lung volume assessed by CT
Time frame: Baseline to 6 months