NCT01783626

Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)

Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +) - A Prospective, Monocenter, Open and Non-randomized Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Evodial
DEVICE	Evodial+ Condition B1
DEVICE	Evodial+ Condition B2
DEVICE	Evodial+ Condition C

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2013-02-05
• Last updated: 2025-03-13

Locations

1 site across 1 country: France