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Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap

NCT02604264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2912

Last updated 2018-09-11

Study results available
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Summary

To assess positive blood cultures (PBCs) in hemodialysis central venous catheter (CVC) patients using two FDA cleared devices: ClearGuard HD end caps compared to conventional end caps.

Conditions

  • End Stage Renal Disease (ESRD)

Interventions

DEVICE

ClearGuard HD end cap

The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub

Sponsors & Collaborators

  • Fresenius Medical Care North America

    collaborator INDUSTRY

  • Pursuit Vascular, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeffrey Hymes, MD · Fresenius Medical Care North America

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-11-30
Completion
2015-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02604264 on ClinicalTrials.gov