NCT00579202

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2007

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

December 19, 2007

Last Update Submit

March 6, 2025

Conditions

Hemodialysis

Keywords

Dialyzer

Outcome Measures

Primary Outcomes (1)

  • For each dialyzer, the perceived ease of priming.

    During priming of each dialyzer

Secondary Outcomes (1)

  • Visual assessment of residual blood in the dialyzer after rinse-back and if dialyzer clotted during treatment.

    At the completion of each treatment

Interventions

Gambro HD-C4 Small DialyzerDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • n/a routine dialysis patients

You may not qualify if:

  • n/a routine dialysis patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Dialysis Center

Lanham, Maryland, 20706, United States

Location

Study Officials

  • Rana Irmindra, M.D.

    Advanced Dialysis Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 21, 2007

Study Start

October 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

March 11, 2025

Record last verified: 2025-03

Locations

US(1)