T-DOC® 5 Fr Pediatric Clinical Investigation

NCT03429270 | Completed Results FDA Device

• 1 other identifier: TDOC5Fr-PEDS-01-PR
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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

Conditions

Incontinence, Urge

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Urodynamics Arm

EXPERIMENTAL

Device: TDOC 5Fr

Interventions

TDOC 5Fr 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

Urodynamics Arm

Eligibility Criteria

• Age: Up to 12 Years
• Gender Eligibility Details: Female and male pediatric
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laborie Medical Technologies Inc.: lead

Study Sites (2)

University of Virginia Health System - UVA - Pediatric Urology Clinic

Charlottesville, Virginia, 22903, United States

Location

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

Morgantown, Virginia, 26506, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stephanie Gallone, Clinical Research Manager
• Organization: Laborie

sgallone@laborie.com

9056121170

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: February 12, 2018
• Study Start: January 22, 2018
• Primary Completion: October 17, 2018
• Study Completion: October 17, 2018
• Last Updated: June 9, 2020
• Results First Posted: June 9, 2020

Record last verified: 2020-05

Locations

US (2)