MedTrace Logo

New Needle for Two-Needle Hemodialysis

NCT01416896 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2011-08-15

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Hemodialysis using the standard venous needle

Hemodialysis using the standard venous dialysis needle

PROCEDURE

Hemodialysis using a new venous needle, the "BME needle"

Hemodialysis using a new venous dialysis needle or the "BME needle"

PROCEDURE

Hemodialysis using a new venous needle, the "BME needle"

One hemodialysis using a new venous needle, the "BME needle"

PROCEDURE

Hemodialysis using the standard venous needle

One hemodialysis using the standard venous needle

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Biomedical Enterprises Inc

    lead INDUSTRY

Principal Investigators

  • Alfredo R Zarate, MD · Biomedical Enterprises Inc

  • Pedro A Jose, MD, PhD · Children National Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-09-30
Completion
2012-09-30

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 NCT01416896 on ClinicalTrials.gov