T-DOC® 5 Fr Pediatric Clinical Investigation

Laborie Medical Technologies Inc.28 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Incontinence, Urge

Interventions

TDOC 5FrDEVICE

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

Sex: ALLMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

University of Virginia Health System - UVA - Pediatric Urology Clinic

Charlottesville, Virginia, United States

J.W. Ruby Memorial Hospital and WVU Medicine Children's

Morgantown, Virginia, United States

Outcomes

Primary Outcomes

The Number of Patients in Which the T-DOC® 5 Fr Catheters Are Safe in Measuring Urodynamic Pressures in Pediatric Subjects (12 Years of Age and Younger).

A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where safety (Yes the device is safe and No the device is not safe) will be reported. A minimum of 10 male and 10 female subjects, with an overall minimum of 28, and maximum of 33 subjects.

Time frame: 2 months

The Number of Patients in Which the T-DOC® 5 Fr Catheters Are Effective in Measuring Urodynamic Pressures in Pediatric Subjects (12 Years of Age and Younger).

A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where effectiveness (Yes the device is effective and No the device is not effective) will be reported. A minimum of 10 male and 10 female subjects, with an overall minimum of 28, and maximum of 33 subjects.

Time frame: 2 months

Data from ClinicalTrials.gov

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