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A Study of the PedSCath Pediatric Sampling Catheter Versus Current Standard of Care.

NCT04763967 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2023-06-22

No results posted yet for this study

Summary

This is a retrospectively-controlled clinical trial that will examine the rate of positive UTI cases among pediatrics entered into the Emergency Department and whose urine is withdrawn using the PedSCath Pediatric Sampling Catheter. The rate of postive UTI will be compared against the control population, whose urine withdrawal would have been performed with Standard of Care devices.

Conditions

  • Urinary Tract Infections in Children

Interventions

DEVICE

PedSCath Pediatric Urinary Catheter

PedSCath Pediatric Sampling Catheter is a pediatric sampling catheter. The product is supplied as a catheter and syringe. PedSCath Pediatric Sampling Catheter is manufactured by Medical Murray Inc. for Big Blue Biotech. The device consists of a blend of LDPE/Elvax/Crodamide.

DEVICE

Standard of Care

Current Standard of Care for pediatric patients

Sponsors & Collaborators

  • Big Blue Biotech, Inc.

    lead INDUSTRY

Principal Investigators

  • Evan M Haynes, MA · Big Blue Biotech, Inc.

Eligibility

Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-27
Primary Completion
2023-02-02
Completion
2023-02-02
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 NCT04763967 on ClinicalTrials.gov