|
General |
Study Status |
Delayed |
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.
|