T-DOC® 5 Fr Pediatric Clinical Investigation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-22

Study Completion Date

2018-10-17

Brief Summary

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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

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Detailed Description

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Conditions

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Incontinence, Urge

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Urodynamics Arm

Group Type EXPERIMENTAL

TDOC 5Fr

Intervention Type DEVICE

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

Interventions

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TDOC 5Fr

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

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes