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New Needle for Two-Needle Hemodialysis — BME-1  

End Stage Renal Disease Clinical Trial

Official title:
New Needle for Two-Needle Hemodialysis

Clinical Trial Summary

Our preliminary studies have demonstrated that an innovative new design of the hemodialysis venous needle (the needle that returns the cleaned blood from the hemodialysis filter to the patient) with three jets is superior to the standard venous needle because it decreases the velocity and turbulence of the blood when compared with the standard venous needle, it is more efficient in the removal of toxins from the blood, and it is safe and effective. More importantly, our preliminary studies suggested that the new needle causes less damage to the dialysis vascular access and to circulating blood cells and less inflammation and oxidative stress. These will decrease medical complications, the high cost of care and death in dialysis patients. The current study will corroborate the finding of previous studies.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01416896
Study type Interventional
Source Biomedical Enterprises Inc
Contact Pedro A Jose, MD, PhD
Phone 202-476-5715
Email pjose@cnmc.org
Status Recruiting
Phase Phase 2/Phase 3
Start date August 2011
Completion date September 2012
View Details
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