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Premarket Clinical Safety Assessment of the ELISIO™-HX

NCT07058909 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-03-06

No results posted yet for this study

Summary

The primary safety objective of this study is to evaluate the safety of the use of the high-permeability hemodialyzer series ELISIO™-HX, by showing that the pre-dialysis albumin levels are not affected using the investigational dialyzer.

The primary efficacy objective is to evaluate the performance of the use of the high permeability hemodialyzer series ELISIO™-HX, by showing that the clearance rate of middle molecular weight lambda (λ) free light chain (FLC) is improved by using the investigational dialyzer.

Conditions

Interventions

DEVICE

ELISIO™-HX Dialyzer

Following consent, participants will undergo a baseline hemodialysis treatment with their currently used dialyzer, the ELISIO-H™, and following the baseline visit will receive hemodialysis with the investigational device, ELISIO™-HX, three times a week for 12 weeks.

Sponsors & Collaborators

  • Bright Research Partners

    collaborator INDUSTRY

  • Nipro Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Kiranjit Dhillon, MD, MPH · Davita Norfolk Dialysis Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-08
Primary Completion
2026-02-25
Completion
2026-02-25
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07058909 on ClinicalTrials.gov