Recruiting

CLINICAL SAFETY ASSESSMENT OF ELISIO™-HX DEVICE FOR TREATMENT

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study AimThis study evaluates the safety of the ELISIO™-HX device for treatment. We will measure any changes in your serum albumin level and the reduction ratio of lambda free light chains.
What is being tested

ELISIO™-HX Dialyzer

Device
Who is being recruted

Renal Failure
+2

+ Acute Renal Failure
+ Chronic Renal Failure
Over 18 Years
+32 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional
Study Start: September 2025

See protocol details

Summary

Principal SponsorNipro Medical Corporation
Study ContactJessica Oswald-McLeod
Last updated: September 16, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 8, 2025Actual date on which the first participant was enrolled.

This study focuses on assessing the safety and effectiveness of the ELISIO™-HX, a type of hemodialyzer used in dialysis treatments. Dialysis is a procedure for people with kidney problems that helps clean the blood of waste products. The study aims to ensure that using this new type of hemodialyzer does not lower the levels of a protein called albumin in the blood, which is important for maintaining health. Additionally, it seeks to determine if the device better removes certain harmful substances from the blood compared to existing options, which could lead to improved treatment outcomes for dialysis patients. Participants in the study will undergo dialysis sessions using the ELISIO™-HX hemodialyzer. Researchers will carefully monitor the patients' pre-dialysis albumin levels to ensure they remain stable, indicating the device's safety. The effectiveness is measured by checking how well the device removes a specific waste product, known as the lambda free light chain, from the blood. This study does not specify any direct risks or benefits, but the main focus is to confirm that the new device is safe and potentially more effective in treating patients undergoing dialysis.

Official TitlePremarket Clinical Safety Assessment of the ELISIO™-HX 
Principal SponsorNipro Medical Corporation
Study ContactJessica Oswald-McLeod
Last updated: September 16, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
15 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Renal Failure
Acute Renal Failure
Chronic Renal Failure
Chronic Kidney Diseases
End Stage Renal Disease
Criteria
10 inclusion criteria required to participate
End stage renal disease patients on hemodialysis age 22 and older, or between ages 18 and 21 with a weight ≥40 kg
Clinically stable as judged by the treating physician and as demonstrated by stable medical history for 30 days prior to enrollment, physical examination, and laboratory testing
Hemodialysis therapy with the ELISIO-H dialyzer for at least 3 months immediately prior to study enrollment and expected to survive for the next 12 months
Expected to maintain an acceptable urea clearance (Kt/V) with a dialyzer of an approximate surface area of 1.7 m2

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22 exclusion criteria prevent from participating
Are female and pregnant, lactating, or planning to become pregnant during the study period. Note: Female participants of childbearing potential, defined as a woman <55 years old who has not had a partial or full hysterectomy or oophorectomy, must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test at screening. Participants of childbearing potential must use a medically acceptable means of contraception during their participation in the study
Have chronic liver disease
Have a known paraprotein-associated disease
Have known bleeding disorders (e.g., gastrointestinal bleeding, colonic polyps, small bowel angiodysplasia, and active peptic ulcers)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
The ELISIO™-HX is a single use novel medium cut-off dialyzer that is intended for use as an artificial kidney for the treatment of participants with renal failure.
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Davita Clinical ResearchNorfolk, United StatesSee the location
Recruiting
One Study Center