Ease of Use Study for the Gambro Polyflux HD-C4 Small Dialyzer

NCT ID: NCT00579202

Last Updated: 2025-03-11

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

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2007-11-30

Brief Summary

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The purpose of the study is to study the ease of use of the Polyflux HD-C4 Small dialyzer under conditions of routine clinical use for hemodialysis

Detailed Description

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Market evaluation protocol.

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 strictly aimed at obtaining feedback from the nursing and technical staff regarding the use of the Polyflux HD-C4 Small dialyzer. The dialysis nursing staff will complete ease of use assessments following routine dialysis therapy.

Conditions

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Hemodialysis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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Gambro HD-C4 Small Dialyzer

Involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* n/a routine dialysis patients

Exclusion Criteria

* n/a routine dialysis patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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

Principal Investigators

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Rana Irmindra, M.D.

Role: PRINCIPAL_INVESTIGATOR

Advanced Dialysis Center

Locations

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Advanced Dialysis Center

Lanham, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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07-0002

Identifier Type: -

Identifier Source: org_study_id

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