Emphysema
Conditions
Brief summary
Use of the Chartis® Assessment System prior to EBV Treatment
Detailed description
This is a multi-center study which will enroll up to 120 patients. Subjects will undergo a Chartis Assessment prior to EBV treatment. The Chartis assessment will determine the presence or absence of collateral ventilation, a potential determining factor in the success of EBV therapy. This study is not randomized; all subjects are eligible to receive EBV Treatment, regardless of Chartis Assessment outcome. Follow-up data will only be collected on those patients that meet the Chartis inclusion criteria.
Interventions
DEVICEChartis System
The Chartis System provides a value that represents the quantification of the average resistance to airflow through collateral airways.
DEVICEEndobronchial Valve (EBV) Treatment
The endobronchial valve is designed to induce target lobe volume reduction.
Sponsors
Pulmonx Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Heterogeneous emphysema * Able to obtain a Chartis value during Assessment
Exclusion criteria
* Any co-existing major medical problems that would not make it possible for the subject to tolerate a bronchoscopic procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lung Volume Change | 30 Days |
Countries
Germany, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm--CV Negative This arm had emphysema and was determined during bronchoscopy to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System. | 62 |
| Treatment Arm--CV Positive This arm had emphysema and was determined during bronchoscopy to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System. | 34 |
| Total | 96 |
Baseline characteristics
| Characteristic | Treatment Arm--CV Negative | Treatment Arm--CV Positive | Total |
|---|---|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 10 | 63 years STANDARD_DEVIATION 9 | 63 years STANDARD_DEVIATION 9 |
| Region of Enrollment Germany | 34 participants | 23 participants | 57 participants |
| Region of Enrollment Netherlands | 21 participants | 9 participants | 30 participants |
| Region of Enrollment Sweden | 7 participants | 2 participants | 9 participants |
| Sex: Female, Male Female | 30 Participants | 19 Participants | 49 Participants |
| Sex: Female, Male Male | 32 Participants | 15 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 51 | 0 / 29 |
| serious Total, serious adverse events | 6 / 51 | 5 / 29 |
Outcome results
Primary
Lung Volume Change
Time frame: 30 Days
Population: Per protocol population analyzed \[16 subjects have been excluded due to the following reasons: lacked HRCT(n=6), Lost to Follow-Up (n=8) or died (n=2) of unrelated causes\].
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Arm--CV Negative | Lung Volume Change | 56 percent decrease in lung volume |
| Treatment Arm--CV Positive | Lung Volume Change | 6 percent decrease in lung volume |