- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 11355
- NewYork-Presbyterian Queens
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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PedSCath
Subjects in this arm will be catheterized with the PedSCath Pediatric Urinary Cather.
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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.
Other Names:
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Retrospective Control
Generated from 2016 and 2018 anonymized subject data from the clinical sites.
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Current Standard of Care for pediatric patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary effectiveness endpoint is the proportion of PedSCath subjects with positive UTI diagnosis versus that of Control subjects.
Time Frame: Through study completion, an estimation of 1 year.
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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.
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Through study completion, an estimation of 1 year.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Evan M Haynes, MA, Big Blue Biotech, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BBBInc: 0619
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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