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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P130008 / PAS001 |
| Date Original Protocol Accepted |
04/30/2014
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| Date Current Protocol Accepted |
04/30/2014
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| Study Name |
Ext FU Premkt Cohort Inspire 4 STAR Trial
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| Device Name |
INSPIRE II UPPER AIRWAY STIMULATOR
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
to demonstrate long-term safety - Prospective, single arm cohort study
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| Study Population |
Subjects implanted with the Inspire UAS System under the premarket study.
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| Sample Size |
Approximately 124 STAR trial subjects are available for the
extended follow-up
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| Key Study Endpoints |
Long term safety of the Inspire system will be assessed via the description of all reported adverse events. Adverse events captured in the premarket study will be summarized by seriousness, severity, relatedness to the device and temporal relationship to the procedure, annually.
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| Follow-up Visits and Length of Follow-up |
5 years post-implant
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
126 patients were enrolled in the study. Of those, 97 patients were followed-up for a maximum duration of 60 months post-procedure.
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| Actual Number of Sites Enrolled |
25 clinical sites (15 U.S. and 10 Europe)
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| Patient Follow-up Rate |
60 months follow-up rate was 97 out of 126 or 76.3%.
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| Final Safety Findings |
Serious adverse events: During the 60-months follow-up, 9 device, procedure- or therapy-related serious adverse events (SAEs) occurred in 8 out of 126 (6.3%) patients. All SAEs involved revision/repositioning (n=5) or replacement (n=4) of the device. Revisions and replacements surgeries did not incur complications or significant sequalae. In addition, there were 5 deaths, all of which were unrelated to device, procedure or therapy.
Non-serious adverse events: 122 out of 126 patients experienced a total of 1,014 non-serious AEs, with 520 (51.3%) of these AEs in 108 patients being unrelated to the device, therapy or procedure and 494 (48.7%) of these AEs being related to the device / therapy (318 AEs in 104 patients) or procedure (176 AEs in 76 patients). The sponsor considered an AE to be procedure-related if it occurred within 30 days post-procedure and device- or therapy-related if it occurred after 30 days post-procedure.
As patients completed their final follow-up visit and exited the study, there were 15 open events (‘Discomfort due to electrical stimulation’ (n=5); ‘Tongue abrasion’(n=3); ‘Mouth dryness’(n=4); ‘Intermittent discomfort from the IPG’ (n=1); ‘Other acute symptoms’ (n=1)) in 12 subjects that had not yet resolved. According to the sponsor, some remained open due to late onset of the event that required time to manage and monitor to closure, however others had been monitored throughout the study, but without resolution.
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| Final Effect Findings |
Key effectiveness findings were based on a subset of the original 126 patients, depending on data availability, ranging between 113 patients and 90 patients. For the most part, effectiveness findings were not statistically significant, although there were some clinically meaningful findings.
The mean FOSQ score at 60-months follow-up visit was 18.0 +/- 2.2, which is higher than the clinically meaningful value of 17.9. At other follow-up times, the mean FOSQ score was less than 17.9, making it not clinically meaningful. Furthermore, the mean change in FOSQ score from baseline was negative at each follow-up visit, suggesting no clinically meaningful improvement in FOSQ score from baseline, since a positive change in FOSQ score of 2.0 is considered clinically meaningful.
The mean ESS score at each follow-up time was less than 10, making it clinically meaningful. although there is no minimum ESS change that can be considered clinically meaningful, the ESS change from baseline is expected to be negative if the patient was to improve over time. On average, ESS change from baseline at each follow-up vist was positive, suggesting no clinically significant improvement in ESS score over time.
On average, AHI was 32.0 +/- 11.0 at baseline and 12.4 +/- 16.3 at 60 months follow-up. On average, ODI was 28.9 +/- 18.2 at baseline and 9.9 +/- 14.5 at 60 months of follow-up. These findings suggest improvement in AHI and ODI over time.
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| Study Strengths & Weaknesses |
Study Strengths:
Prospective cohort study is gold standard for epidemiologic studies.
Long-term follow-up (up to 5 years)
Safety and effectiveness were evaluated using multiple outcome measures.
Study weaknesses:
Descriptive study
Follow-up rate is < 80%
Not all patients with adverse events had known outcomes.
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| Recommendations for Labeling Changes |
Labeling changes are recommended labeling based on safety and effectiveness data reported in the final report
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