|
|
| General |
| Study Status |
Ongoing |
| 522 Number / Requirement Number |
PS200001 / PSS001 |
| Date Original Plan Accepted |
05/29/2020
|
| Date Current Plan Accepted |
12/29/2022
|
| Study Name |
Ellipsys Vascular Access System PS Study
|
| Device Name |
Ellipsys vascular access system
|
| Root Document Number |
DEN170004
|
| 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 |
Prospective, multi-center, single-arm, non-randomized, observational, post-market surveillance (PS) study.
The primary objective of this post-market surveillance study is to support the short-term safety of the device and procedure and further assess long-term safety and effectiveness in subjects treated by newly trained providers of the Ellipsys Vascular Access System in the creation of a native AV fistula via percutaneous access in subjects who are on hemodialysis and are medically indicated for the creation of an upper limb anastomosis.
|
| Study Population |
patients who are on hemodialysis and are medically indicated for the creation of upper limb anastomosis.
|
| Sample Size |
Up to 134, over 14 US sites
|
| Key Study Endpoints |
Primary Safety Endpoint:
Early Occlusion, Study Related Serious Adverse Events through 12 months
Primary Effectiveness Endpoint:
Cumulative Patency through 12 months post-AVF creation
|
| Follow-up Visits and Length of Follow-up |
12 months
|
| Interim or Final Data Summary |
| Interim Results |
No interim results have been reported to date.
|
| Actual Number of Patients Enrolled |
2
|
| Actual Number of Sites Enrolled |
4
|
| Patient Followup Rate |
100%
|
| Study Strengths and Weaknesses |
This study is ongoing and the results are interim. Final analyses of endpoints will not be completed until the study
concludes.
|
