|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P200036 / PAS001 |
| Date Original Protocol Accepted |
03/01/2022
|
| Date Current Protocol Accepted |
07/15/2022
|
| Study Name |
Continued Follow-Up of G170301 Clinical Study
|
| Device Name |
eCoin Peripheral Neurostimulator
|
| Clinical Trial Number(s) |
NCT03556891
|
| General Study Protocol Parameters |
| Study Design |
Active Surveillance
|
| Data Source |
Other Data Source
|
| Comparison Group |
Device Subjects Serve as Own Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up of premarket cohort to obtain longer term safety and effectiveness data on the eCoin out to 5 years post-implantation
|
| Study Population |
Subjects diagnosed with Urgency Urinary Incontinence (UUI).
|
| Sample Size |
Available sample size for longer term follow-up of the original cohort.
The original IDE study was designed to enroll and implant between 120 and 135 patients; it enrolled 137 patients with 4 patients exiting prior to implantation (due to ineligibility). Thus, 133 patients were implanted.
|
| Key Study Endpoints |
To collect and report clinical outcomes for safety and effectiveness, including 3-day bladder diaries, all device- or procedure-related adverse events, including but not limited to, infections, vasculitis, cellulitis, neuro-sensory and -motor events, device migrations, erosions, unplanned explantations, and re-implantation, to FDA through 5 years post-implantation on patients enrolled in G170301.
|
| Follow-up Visits and Length of Follow-up |
5 years, post-implantation
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
31
|
| Actual Number of Sites Enrolled |
9
|
| Patient Follow-up Rate |
67.7% (21 of 31 at 5 years)
The study reconsented 31 subjects for continued follow-up out to 5 years post-implantation. Of those reconsented, 15 subjects consented to re-enroll for follow-up only (no device re-implantation) and 16 subjects consented to be explanted and re-implanted. Prior to the 205 week follow-up, one subject withdrew and 7 subjects were missing at random. Prior to the 257 week follow-up, 2 additional subjects were missing at random.
|
| Final Safety Findings |
There were no unanticipated adverse device events. Overall, there were 2 device related adverse events: 1 for incisional site pain and 1 procedure-related adverse event of post-operative infection. These events are anticipated for this type of device.
|
| Final Effect Findings |
For subjects who underwent follow up only and were not re-implanted, 75% (9/12 subjects) showed at least a 50% reduction in UUI episodes at 205 weeks, and 58% (7/12 subjects) of subjects experienced at least a 50% reduction in UUI episodes at 257 weeks. Of subjects who were reimplanted, 45% (5/11 subjects) of subjects experienced at least a 50% reduction in UUI episodes at 205 weeks post activation, and 78% (7/9 subjects) experienced at least a 50% reduction in UUI episodes at 257 weeks.
|
| Study Strengths & Weaknesses |
Study shows similar results in terms of safety and effectiveness at 4- and 5-years post-implant compared to the pre-market results. However, the results are based upon a very limited number of patients since many subjects did not reconsent and/or were lost to follow-up. Further, the 4- and 5-year data on re-implanted subjects is difficult to interpret as the time elapsed between the explant and re-implant varied among those subjects. Reimplantation of a new eCoin device did not reset their follow-up clock
|
| Recommendations for Labeling Changes |
None
|
