New Needle for Two-Needle Hemodialysis (BME-1)

BioMedical Enterprises

Status and phase: Unknown; Phase 3; Phase 2

Conditions: End Stage Renal Disease

Treatments: Procedure: Hemodialysis using a new venous needle, the "BME needle"; Procedure: Hemodialysis using the standard venous needle

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT01416896

R44DK059062 (U.S. NIH Grant/Contract)

BME-1

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:(1) end stage renal disease receiving hemodialysis in an ambulatory outpatient dialysis facility (2) male or female, (3) ages 18-80, (4) arterio-venous graft or AV fistula as vascular access,

Exclusion Criteria:patients with fever, infection, inflammation or malignancy will be excluded

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

New venous needle, the "BME needle"

Experimental group

Description:

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

Treatment:

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

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

Standard venous needle, the "standard needle"

Active Comparator group

Description:

One hemodialysis using the standard venous needle, the "standard needle" (device).

Treatment:

Procedure: Hemodialysis using the standard venous needle

Procedure: Hemodialysis using the standard venous needle