CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
ELISIO-15H +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02433210
NCT02433210N/ACompleted
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A Clinical Study Comparing the Basic Performance and Blood Compatibility Characteristics of Nipro ELISIO-H, Gambro Polyflux Revaclear and Fresenius Optiflux Dialyzers

University of Missouri-Columbia·interventional·Posted May 4, 2015·Updated Aug 5, 2022

In Brief

A clinical study evaluating ELISIO-15H, Revaclear, and 1 other intervention for End Stage Renal Disease (ESRD). Completed, enrolled 11 participants across 1 site.

Detailed Summary

The aim of the study is to confirm the safety and clinical effectiveness of Nipro ELISIO-15H and to compare its performance characteristics and hemocompatibility with those of the commercially available dialyzers in U.S.A., Gambro Polyflux Revaclear and Fresenius F160NRe. 10 stable patients will be dialyzed 3 times/week with each dialyzer over 3 weeks. Blood samples for several parameters will be collected during hemodialysis to assess the performance and hemocompatibility of the dialyzers under study. Data thus collected will be analyzed for comparison by standard statistical analysis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease (ESRD)
CountriesUnited States
CollaboratorsNipro Medical Corporation, Dialysis Clinic, Inc.

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 4, 2015
Enrollment StartJun 1, 2015
Primary CompletionNov 30, 2017
Study CompletionAug 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.2 years ago

Interventions

ELISIO-15Hdevice

Each patient to undergo 3 successive hemodialysis/week with this dialyzer.

Revacleardevice

Each patient to undergo 3 successive hemodialysis/week with this dialyzer.

Optifluxdevice

Each patient to undergo 3 successive hemodialysis/week with this dialyzer.