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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160039 / PAS001 |
| Date Original Protocol Accepted |
12/21/2017
|
| Date Current Protocol Accepted |
|
| Study Name |
Post-Approval Study
|
| Device Name |
remede® System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, multicenter, single arm cohort study to evaluate long-term safety, long-term effectiveness, and survival rate in the continued follow-up of the premarket cohort for the remede System Pivotal Trial.
|
| Study Population |
Subjects who were previously implanted with the remede System and participated in the remede System Pivotal Trial
|
| Sample Size |
Up to 94 subjects are available for the extended follow-up
|
| Key Study Endpoints |
1. Evaluate the survival rate
2. Evaluate long-term three and five-year device-related SAEs
3. Evaluate long-term three and five-year therapy-related SAEs
4. Evaluate the AHI, CAI and obstructive apnea index (OAI)
5. Evaluate the change in quality of life from Baseline
|
| Follow-up Visits and Length of Follow-up |
Follow-up is planned for five years from the date of implant. Since all subjects have already completed 24 months of follow-up, total study duration is estimated to be three years.
30, 36, 42, 48, 54, 60 months follow-up assessments planned
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
53
|
| Actual Number of Sites Enrolled |
18
|
| Patient Follow-up Rate |
30 month (0%), 36 month (0%), 42 month (17%), 48 month (45%), 54 month (73%), 60 month (98%) follow-up assessments
|
| Final Safety Findings |
There were no unanticipated adverse events or significant increase in events. There have been no deaths attributed to the device, procedure or delivered therapy, and the survival rates were comparable with other published data sets.
|
| Final Effect Findings |
The results continue to show a sustained improvement at similar levels as demonstrated in the pivotal trial for apnea-hypopnea index (AHI), central apnea index (CAI) as well as Epworth Sleepiness Scale (ESS).
|
| Study Strengths & Weaknesses |
Weaknesses: Poor enrollment (53 of 94 eligible subjects, 56%) and missed follow-up assessments due to slower than anticipated enrollment of subjects.
Strengths: There was a high follow up rate at the 60 month visit (52 of 53 subjects enrolled, 98%), and this visit included assessment of all endpoints for safety and effectiveness, including an in-lab PSG study.
|
| Recommendations for Labeling Changes |
The safety and effectiveness data were similar to those previously reported in the pivotal trial and no new safety signal has been identified. Therefore, no labeling change is recommended.
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