New Needle for Two-Needle Hemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reduction of Microemboli of Air Using a New Developed Air Trap (EmbolessTM) During Haemodialysis

NCT06168539

Hemodialysis Complication Air Embolism Extracorporeal Circulation; Complications

COMPLETED NA

Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis

NCT05493423

End Stage Renal Disease

COMPLETED NA

VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC

NCT02685995

Renal Failure Chronic Requiring Hemodialysis Chronic Renal Insufficiency

COMPLETED NA

Three-dimensional (3D) Printed Hemodialysis Vascular Model

NCT05096416

Hemodialysis Access Failure

NOT_YET_RECRUITING NA

A Comparative Study of Two Kinds of Hemodialysis Filters

NCT05899283

Uremia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End Stage Renal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

New venous needle, the "BME needle"

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

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

Intervention Type PROCEDURE

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

Standard venous needle, the "standard needle"

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

Group Type ACTIVE_COMPARATOR

Hemodialysis using the standard venous needle

Intervention Type PROCEDURE

Hemodialysis using the standard venous dialysis needle

Hemodialysis using the standard venous needle

Intervention Type PROCEDURE

One hemodialysis using the standard venous needle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hemodialysis using the standard venous needle

Hemodialysis using the standard venous dialysis needle

Intervention Type PROCEDURE

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

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

Intervention Type PROCEDURE

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

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

Intervention Type PROCEDURE

Hemodialysis using the standard venous needle

One hemodialysis using the standard venous needle

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

hemodialysis using the standard venous dialysis needle The "BME needle" is a newly designed venous dialysis needle.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No