Back to resultsT-DOC® 5 Fr Pediatric Clinical Investigation
Primary Purpose
Incontinence, Urge
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TDOC 5Fr
Sponsored by
About this trial
This is an interventional other trial for Incontinence, Urge
Eligibility Criteria
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
Sites / Locations
- University of Virginia Health System - UVA - Pediatric Urology Clinic
- J.W. Ruby Memorial Hospital and WVU Medicine Children's
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Urodynamics Arm
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03429270
First Posted
January 19, 2018
Last Updated
May 27, 2020
Sponsor
Laborie Medical Technologies Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03429270
Brief Title
T-DOC® 5 Fr Pediatric Clinical Investigation
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
October 17, 2018 (Actual)
Study Completion Date
October 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laborie Medical Technologies Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence, Urge
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Urodynamics Arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
TDOC 5Fr
Intervention Description
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
Primary Outcome Measure Information:
Title
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).
Description
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
Title
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).
Description
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
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Female and male pediatric
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Virginia Health System - UVA - Pediatric Urology Clinic
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
J.W. Ruby Memorial Hospital and WVU Medicine Children's
City
Morgantown
State/Province
Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Learn more about this trial
T-DOC® 5 Fr Pediatric Clinical Investigation
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