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

NCT04763967 | Terminated FDA Device

• 1 other identifier: BBBInc: 0619
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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will examine the rate of positive UTI cases among pediatrics entered into the Emergency Department and whose urine is withdrawn using the PedSCath Pediatric Sampling Catheter.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

Outcome Measures

Primary Outcomes (1)

• The primary effectiveness endpoint is the proportion of PedSCath subjects with positive UTI diagnosis versus that of Control subjects.

  The primary effectiveness endpoint is the proportion of PedSCath subjects with positive UTI diagnosis versus that of Control subjects. The objective is to demonstrate a lower rate of positive urinalysis/urine culture results in the PedSCath cohort.

  Through study completion, an estimation of 1 year.

Study Arms (2)

PedSCath

Subjects in this arm will be catheterized with the PedSCath Pediatric Urinary Cather.

Device: PedSCath Pediatric Urinary Catheter

Retrospective Control

Generated from 2016 and 2018 anonymized subject data from the clinical sites.

Device: Standard of Care

Interventions

PedSCath Pediatric Urinary Catheter DEVICE

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.

Also known as: Wiygul Catheter

PedSCath

Standard of Care DEVICE

Current Standard of Care for pediatric patients

Retrospective Control

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Prospective cohort subjects will enter the emergency department presenting symptoms of UTI. The Control group will be retrospectively enrolled by gathering data through anonymized 2016 and 2018 subject data gathered from the study's clinical sites.

You may qualify if:

• Subject is 3 years of age or younger.
• Subject is non-toilet trained, as communicated by subject's parent/guardian.
• Subject is presenting to the emergency department with symptoms for UTI, as described by AAP guidelines (Newborns with UTI may present with jaundice, sepsis, failure to thrive, vomiting, or fever. In infants and young children, typical signs and symptoms include fever, strong-smelling urine, hematuria, abdominal or flank pain, and new-onset urinary incontinence) or as determined by PI.
• Subject's parent/guardian is able to provide informed consent.

You may not qualify if:

• Any subject with known underlying abnormalities to the genitourinary tract (e.g. prenatal hydronephrosis).
• Any subject who has had prior genitourinary tract or abdominal surgery.
• Any subject who is toilet trained (i.e. able to provide a clean catch urine sample).
• Any subject with an active rash or skin lesion in the suprapubic area.
• Any subject with a known allergy to LDPE, Elvax, or Crodamide plastics.

Sponsors & Collaborators

• Big Blue Biotech, Inc.: lead

Study Sites (1)

NewYork-Presbyterian Queens

New York, New York, 11355, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples are collected for both Urinalysis and Urine Culture. Both Urinalysis samples and Urine Culture are retained for 1 Week.

Study Officials

• Evan M Haynes, MA

  Big Blue Biotech, Inc.

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: February 21, 2021
• Study Start: August 27, 2021
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (1)