T-DOC® 5 Fr Pediatric Clinical Investigation

Incontinence, Urge Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429270
• Other study ID #: TDOC5Fr-PEDS-01-PR
• Status: Completed
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: October 17, 2018

Study information

• Verified date: May 2020
• Source: Laborie Medical Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 17, 2018
• Est. primary completion date: October 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Incontinence, Urge
• Urinary Incontinence, Urge

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Laborie Medical Technologies Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 months
Primary	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.	2 months