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|
| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS160003 / PSS001 |
| Date Original Plan Accepted |
10/07/2016
|
| Date Current Plan Accepted |
10/07/2016
|
| Study Name |
Indego Postmarket Surveillance Study
|
| Device Name |
Indego
|
| Root Document Number |
K152416
|
| General Study Protocol Parameters |
| Study Design |
Enhanced Surveillance
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a post-market registry-based “Enhanced Surveillance” study involving newly enrolled subjects that will collect data on “Indego”-related adverse events (including serious adverse events) such as falls and device malfunctions experienced by institutions, clinicians, personal users and support persons. The sponsor will monitor distribution and trends in incidence of MDR and non-MDR reportable events through ongoing, passive but systematic collection, analysis and interpretation of data. The sponsor will monitor an online data repository (registry) and perform active follow-up according to a pre-specified schedule.
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| Study Population |
The study population consists of Institutional sites (Group #1), Personal users (Group #2), Support Persons (Group #3) as well as Indego Trainers and Instructors (Group #4). Inclusion and Exclusion criteria were specified for Group #2.
|
| Sample Size |
The estimated samples sizes are as follows: Institutional sites (n=10)
Personal users (n=15) Support Persons (n=15)
“Indego” Trainers and Instructors (n=10).
Note: In order to justify the sample size of 15 personal users and 15 support persons, the sponsor also specified that if the patient uses this device 3x per week for 12 months after training, a total of 2,340 sessions will be represented in the home and community setting at the end of the study.
|
| Key Study Endpoints |
Main safety endpoints:
Group 1-3: Number of “Indego-related” AEs and SAEs, such as falls and device malfunctions, including detailed information regarding circumstances surrounding such events.
Group 1: Safety of Indego use based on Registry Report
Form.
Group 2: Questions and concerns related to “Indego” based
on Personal use questionnaire.
Group 3: Questions and concerns related to “Indego” based
on Support person questionnaire.
Main Effectiveness Endpoints:
Group 1: Ease of Use; Quality of Indego Training.
Group 2: Quality of “Indego” Training and Comfort level with “Indego” based on Personal use questionnaire.
Group 3: Quality of “Indego” Training and Comfort level with “Indego” based on support person questionnaire; Proficiency / use maintained 12 months after completion of training program.
Group 4: Failure to complete personal use training program and rationale for failure.
|
| Follow-up Visits and Length of Follow-up |
For Group 1, the duration of follow-up will be 24 months. For Groups 2-4, the duration of follow-up will be 12 months
|
| Interim or Final Data Summary |
| Recommendations for Labeling Changes |
1. Applicable safety and effectiveness findings reported in the final report for the postmarket surveillance study should be added to the device labeling.
2. We recommend the device labeling include a complete description of the “Dance Mode,” including how the device achieves its intended purpose and how the user can activate and disable this mode as this information is not included in the user manual and could lead to a potential adverse event.
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