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Dialysis Catheter Comparative Clinical Trial | Clinical Trials | Clareo Health

COMPLETEDNA

Dialysis Catheter Comparative Clinical Trial

A Randomized, Open-label Comparison of the Performance and Longevity of a Split-tip Versus a Symmetric Tip Hemodialysis

NCT00526123•Tyco Healthcare Group

View on ClinicalTrials.gov

Summary

The purpose of this clinical trial is to compare the longevity of two dialysis catheters.

Detailed Description

This study is a multi-center, randomized, prospective, open-label, clinical study comparing a conventional split-tip catheter and a symmetric tip catheter in subjects undergoing hemodialysis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject must be 18 years of age or older.
•Subject must meet labeled indication for hemodialysis.
•Subject must have End Stage Renal Disease (ESRD).
•Subject must have a patent right or left internal jugular vein.
•Subject treatment plan must require chronic hemodialysis treatments 3 times per week for a minimum of 6 weeks.
•Subject must give written informed consent.

Exclusion Criteria

•Subjects who are concurrently enrolled in any Randomized Clinical Trial (RCT) or those that may enroll in a RCT during the course of the study, or subjects who have been previously randomized into this clinical study.
•Subjects with active infection at the time of study enrollment.
•Subjects with a known sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia.
•Subjects with uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding.
•Subjects who are known or suspected to be pregnant at the time of study enrollment or plan to get pregnant during the study period.
•Subjects for whom performing dialysis at flow rates up to 450 mL/min would be contraindicated for any reason.
•Subject unable or unwilling to commit to follow-up visits and study procedures throughout the course of the study.
•Subjects who, in the opinion of the Investigators, are not appropriate candidates for the study based upon current or past medical history, or negative past experience with either of the study catheters.

Locations (14)

Nephrology Associates, P.C.

Birmingham, Alabama, United States

Southwest Kidney Institute

Phoenix, Arizona, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

SUNY Stony Brook Medical Center

Stony Brook, New York, United States

Eastern Nephrology Associates

Greenville, North Carolina, United States

Eastern Nephrology Associates

New Bern, North Carolina, United States

Boice-Willis Clinic

Rocky Mount, North Carolina, United States

Dialysis Access Group of Wake Forest University, LLC

Winston-Salem, North Carolina, United States

Toledo Hospital

Toledo, Ohio, United States

Key Dates

Start Date

September 1, 2007

Primary Completion Date

August 1, 2011

Completion Date

August 1, 2011

Last Updated

January 7, 2013

Enrollment

599

ACTUAL participants

Conditions

End Stage Renal Disease

Interventions

Symmetric Tip Catheter

DEVICE

Conventional Split-tip Catheter

DEVICE

EndoForce Post Approval Study

NCT07146854

End Stage Renal Disease (ESRD)

View study

RECRUITINGNA

Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

NCT04163614

End Stage Renal DiseaseHypertension+2 more

View study

RECRUITINGPHASE2

Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dialysis Catheter Comparative Clinical Trial

Inclusion Criteria

Exclusion Criteria

EndoForce Post Approval Study

Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD

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