Ease of Use and Blood Clotting for the Gambro Polyflux HD-C4 Big Dialyzer

NCT ID: NCT00659724

Last Updated: 2025-07-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-05-31

Brief Summary

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The purpose of this study is to collect information on the ease of use and thrombogenicity of the Polyflux HD-C4 Big and Fresenius Optiflux 180NR or 200NR dialyzers under conditions of routine clinical use for hemodialysis.

Detailed Description

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This ease of use study involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy. This study is aimed at obtaining feedback from the nursing and technical staff regarding the use and thrombogenicity of the Polyflux HD-C4 Big, and Fresenius Optiflux 180NR or 200NR dialyzers. The dialysis nursing staff will complete ease of use and thrombogenicity assessments following routine dialysis therapy. Any adverse events will be tracked for the study patients.

Conditions

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Chronic Kidney Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Hemodialysis patients 18 years of age or older

Exclusion Criteria

* n/a
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanced Dialysis Center of Potomac

INDUSTRY

Sponsor Role collaborator

Advanced Dialysis Center of Easton

INDUSTRY

Sponsor Role collaborator

Gambro Renal Products, Inc.

INDUSTRY

Sponsor Role collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Vantive Health LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Advanced Dialysis Center of Easton

Easton, Maryland, United States

Site Status

Advanced Dialysis Center of Potomac

Arlington, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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Gambro 1462

Identifier Type: -

Identifier Source: org_study_id

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