Status:
COMPLETED
T-DOC® 5 Fr Pediatric Clinical Investigation
Lead Sponsor:
Laborie Medical Technologies Inc.
Conditions:
Incontinence, Urge
Eligibility:
All Genders
Up to 12 years
Phase:
NA
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2018
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03429270
Start Date
January 22 2018
End Date
October 17 2018
Last Update
June 9 2020
Active Locations (2)
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1
University of Virginia Health System - UVA - Pediatric Urology Clinic
Charlottesville, Virginia, United States, 22903
2
J.W. Ruby Memorial Hospital and WVU Medicine Children's
Morgantown, Virginia, United States, 26506