NCT04763967

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

A Multi-center, Study of the Non-inferiority of PedSCath Pediatric Sampling Catheter Versus a Retrospective Control Cohort Using Current Standard of Care.

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Big Blue Biotech, Inc. · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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will examine the rate of positive UTI cases among pediatrics entered into the Emergency Department and whose urine is withdrawn using the PedSCath Pediatric Sampling Catheter.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

Detailed description

This will be a multi-center, retrospective-controlled, clinical trial. Anonymized retrospective data from two clinical sites, NewYork-Presbyterian Queens and Weill Cornell Medical College, from 2016 and 2018 will be used to define the control subject population, who were assessed for urinary tract infection (UTI) based on a urine sample taken according to Standard of Care (SoC). Subjects entering the emergency department (ED) generally require that a urine specimen is obtained and tested to determine whether there is an active infection in the bladder. Emergency department personnel will confirm the possibility of UTI based on symptoms and inform the parents/guardians of the potential for study participation using the PedSCath. The physician will assess the subject based on Inclusion and Exclusion criteria, including non-toilet training and an upper age limit of 3 years. If determined that the subject meets inclusion/exclusion criteria, the physician will inform the parents/guardians of the subject about the study and request informed consent if the parents/guardians wish their child to participate. Following the granting of Informed Consent, subjects will be enrolled in the study within the treatment arm and a urine sample of 2-3 ml will be taken via the PedSCath. All study assessments, from enrollment through urine sample collection, will occur over a single visit to the ED. Per standard of care, any treatment following the diagnosis will be performed by hospital staff based on physician assessment. Up to 3 run-in subjects per PedSCath user will be treated with PedSCath to allow PedSCath users to become familiar with PedSCath mechanism.

Conditions

• Urinary Tract Infections in Children

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-08-27
• Primary completion: 2023-02-02
• Completion: 2023-02-02
• First posted: 2021-02-21
• Last updated: 2023-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study