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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Ellipsys Vascular Access System PS Study


 
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General
Study Status Progress Adequate
522 Number / Requirement Number PS200001 / PSS001
Date Current Plan Accepted 06/04/2021
Study Name Ellipsys Vascular Access System PS Study
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 Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a new enrollment, multi-center, single-arm, prospective cohort study with a descriptive analysis plan.

The objectives of the study are to confirm the safety and effectiveness of the device and procedure at short-term and longer-term time points. Additionally, the study is designed to assess the safety of the device and procedure in subjects treated by newly trained providers.
Study Population Description Subjects at least 18 years of age but not more than 80 years of age who have a life expectancy of at least one year, in the investigator’s opinion, are diagnosed with end stage renal disease or chronic kidney disease and are on hemodialysis. Subjects must also meet the other inclusion/exclusion criteria for the study.
Sample Size A minimum of 134 subjects will be enrolled and treated to ensure a minimum of 100 subjects evaluable at the 12-month follow-up visit.
Data Collection The Primary Safety Endpoint will be the early occlusion rate, and the cumulative occlusion rate at 3, 6, and 12 months post-procedure.

The Primary Effectiveness Endpoint will be Secondary Patency at 6- and 12-months post-procedure.

There will be multiple secondary endpoints including: adverse event rates, primary patency rates, assisted primary patency rates, functional cannulation success rates, physiological maturation rates, and an assessment of nurse-cannulator satisfaction with the endoAVF cannulation process.
Follow-up Visits and Length of Follow-up Subjects will be followed for 12 months post endoAVF creation.


Ellipsys Vascular Access System PS Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/29/2020 11/25/2020 On Time
one year report 05/29/2021 05/25/2021 On Time
18 month report 11/29/2021    
two year report 05/29/2022    


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