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

March 6, 2025 updated by: Vantive Health LLC

The Gambro Polyflux HD-C4 Small Ease of Use Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Lanham, Maryland, United States, 20706
        • Advanced Dialysis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The dialysis nursing staff will complete ease of use assessments following routine dialysis therapy of adult (≥ 18 years of age) patients

Description

Inclusion Criteria:

  • n/a routine dialysis patients

Exclusion Criteria:

  • n/a routine dialysis patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
For each dialyzer, the perceived ease of priming.
Time Frame: During priming of each dialyzer
During priming of each dialyzer

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual assessment of residual blood in the dialyzer after rinse-back and if dialyzer clotted during treatment.
Time Frame: At the completion of each treatment
At the completion of each treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vantive Health LLC

Collaborators

Baxter Healthcare Corporation
Gambro Renal Products, Inc.

Investigators

  • Principal Investigator: Rana Irmindra, M.D., Advanced Dialysis Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 19, 2007

First Posted (Estimated)

December 21, 2007

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 07-0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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