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

NCT02593149 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1902

Last updated 2019-02-27

Study results available
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Summary

To assess blood stream infections in participants using two FDA-cleared devices: ClearGuard HD end caps compared to the Tego® connector with the CurosTM for Tego disinfecting port protector.

Conditions

  • End Stage Renal Disease (ESRD)

Interventions

DEVICE

ClearGuard HD End Cap

The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub

Sponsors & Collaborators

  • Davita Clinical Research

    collaborator INDUSTRY

  • Pursuit Vascular, Inc.

    lead INDUSTRY

Principal Investigators

  • Steven M Brunelli, MD, MSCE · DaVita Clinical Research / DaVita HealthCare Partners

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-11-30
Completion
2016-11-30
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 NCT02593149 on ClinicalTrials.gov