T-DOC® 5 Fr Pediatric Clinical Investigation



Status:Recruiting
Healthy:No
Age Range:Any - 12
Updated:8/12/2018
Start Date:January 22, 2017
End Date:October 27, 2018
Contact:Bisma Rizvi
Email:brizvi@laborie.com
Phone:905-612-1170

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Trial Summary
Trial Overview
Inclusion Criteria

A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects

A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged
Catheter for Performing Urodynamic Studies on Pediatric Subjects


Inclusion Criteria:

- Male and Female (Children and infants, 12 years of age and younger)

- Subjects who are scheduled and normally indicated for urodynamics testing, for any
medically necessary reason as per the physician.

Exclusion Criteria:

- Subjects who suffer from bladder infections (not including subjects with asymptomatic
bacteruria)

- Subjects with urethral strictures

- Subjects who require the use of a suprapubic catheter
We found this trial at
2
sites
J.W. Ruby Memorial Hospital and WVU Medicine Children's
1 Medical Center Drive
Morgantown, Virginia 26506
Phone: 304-293-2706
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from
Morgantown, VA
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University of Virginia Health System - UVA - Pediatric Urology Clinic
Charlottesville, Virginia 22903
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mi
from
Charlottesville, VA
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