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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
H060002 / PAS001 |
| Date Original Protocol Accepted |
10/24/2008
|
| Date Current Protocol Accepted |
12/16/2014
|
| Study Name |
IBV Valve
|
| Device Name |
IBV VALVE SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The study is a prospective observational study to collect safety information about the IBV Valve System for the treatment of prolonged air leak. Eligible subjects will be enrolled into the study on the day of valve treatment. The subjects will be monitored after treatment until discharge from the hospital (a minimum of 1 night stay after the procedure). After discharge, the subjects will be seen by the investigator for assessment of air leak status as clinically indicated. Valves will be removed after the air leak is resolved. If the air leak is not resolved, the valves will be removed no longer than 6 weeks after device placement and other options can be considered.
|
| Study Population |
Patients with prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS).
|
| Sample Size |
32 patients will be enrolled at up to 15 clinical sites.
|
| Key Study Endpoints |
The safety endpoints include the total number, rate, type, timing, duration, severity and relationship to device or procedure of adverse events. Probable benefit data includes: 1) A positive response in air leak resolution; 2) Number of days after valve placement.
|
| Follow-up Visits and Length of Follow-up |
The duration of follow-up is a maximum of 6 weeks.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
39
|
| Actual Number of Sites Enrolled |
11
|
| Patient Follow-up Rate |
100% (32/32 as per protocol)
|
| Final Safety Findings |
No unanticipated adverse device effects (UADE) have been reported for the Spiration PAS.
SAE: There have been a total of two reported adverse events in two of the 32 subjects treated. One was serious and one was moderate. Both AEs are summarized below:
Systolic arrest experienced prior to valve placement (day 0): reported as a serious adverse event (SAE), but deemed “Not related” to the device or the procedure. Notes provided on the CRF indicate that the event was due to acidosis from hypercapnia and resolved the same day.
Atelectasis and thick mucus secretions in the left main stem bronchus experienced on day five. One of the four placed valves was removed to treat and meds were given; the event resolved in one day. The investigator deemed this event moderate and “Possibly” related to the device.
|
| Final Effect Findings |
Of the 32 subjects who received valves for treatment of air leak, 30 (94%) showed a positive response to valve placement. Two subjects (6%) showed no improvement in air leak. Of the 30 responders, eleven (11), or 36.7%, were noted as completely resolved. Nineteen (19), or 63.3%, of the subjects were classified as improvement in the air leak. There were no significant differences in the results between
the single use catheter and reloadable catheter groups.
|
| Study Strengths & Weaknesses |
Strength: 100% follow-up
Weaknesses: Limited number of female patients (10), small sample size (32), and no concomitant control group was included.
If a new enrollment Post-Approval Study is required, FDA recommends considering exploring the possibility of using external registry on post-surgical prolonged air leaks data; for example, registries already established created and maintained by a professional organization, academia, and/or government, available inside or outside US, as potential platforms of existing infrastructure to conduct the PAS study.
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| Recommendations for Labeling Changes |
The PAS study design, methods and results must be included in the labeling. Additionally, it should be indicated the reason why seven (7) valves could not being implanted.
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