MedTrace Logo

Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)

NCT01783626 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-03-13

No results posted yet for this study

Summary

Evodial +hemodialyzer consists of an evolution of the existing CE marked Evodial device, with respect to the hemodialyzer membrane removal characteristics. Different membrane prototypes configurations are proposed (3 versions in total), with the objective to modulate the hemodialyzer removal capacities (convective and adsorptive capacities).

Materials(including heparin grafted specifications) as well as the sterilization process are identical to the Evodial hemodialyzer. Based on available preclinical data , a clinical study is requested to document in vivo the different prototypes removal capacities with respect to middle Molecular Weight (MW) reference toxins such as b2 Microglobulin and collect data with regards to protein loss.

Conditions

  • End Stage Renal Disease (ESRD)

Interventions

DEVICE

Evodial

DEVICE

Evodial+ Condition B1

DEVICE

Evodial+ Condition B2

DEVICE

Evodial+ Condition C

Sponsors & Collaborators

  • Gambro Lundia AB

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Vantive Health LLC

    lead INDUSTRY

Principal Investigators

  • Nathalie Loughraieb · Gambro Industries

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • France

More Related Trials

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 NCT01783626 on ClinicalTrials.gov