NCT07058909

Premarket Clinical Safety Assessment of the ELISIO™-HX

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Nipro Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Renal Failure
• Acute Renal Failure
• Chronic Renal Failure
• Chronic Kidney Diseases
• End Stage Renal Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-08
• Primary completion: 2026-02-25
• Completion: 2026-02-25
• First posted: 2025-07-10
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study