T-DOC® 5 Fr Pediatric Clinical Investigation

• Sponsor: Laborie Medical Technologies Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03429270
• Collaborator: (none)
• Enrollment: 28
• Locations: 2
• Arm: 1
• Actual Duration (Months): 8.8
• Patients Per Site: 14
• Patients Per Site Per Month: 1.6

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Incontinence, Urge	Device: TDOC 5Fr	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Jan 22, 2018
• Actual Primary Completion Date: Oct 17, 2018
• Actual Study Completion Date: Oct 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Urodynamics Arm	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

Outcome Measures

Primary Outcome Measures

1. 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). [2 months]

   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. 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). [2 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia Health System - UVA - Pediatric Urology Clinic	Charlottesville	Virginia	United States	22903
2	J.W. Ruby Memorial Hospital and WVU Medicine Children's	Morgantown	Virginia	United States	26506

Sponsors and Collaborators

• Laborie Medical Technologies Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jun 26, 2018
• Statistical Analysis Plan - Jul 9, 2018

More Information

Publications

None provided.

• Responsible Party: Laborie Medical Technologies Inc.
• ClinicalTrials.gov Identifier: NCT03429270
• Other Study ID Numbers: TDOC5Fr-PEDS-01-PR
• First Posted: Feb 12, 2018
• Last Update Posted: Jun 9, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Urinary Incontinence, Urge

Study Results

Participant Flow

Arm/Group Title	Urodynamics Arm
Arm/Group Description	Urodynamic testing and data collection(per protocol) using the TDOC 5Fr catheters.
Period Title: Overall Study
STARTED	28
COMPLETED	28
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Urodynamics Arm
Arm/Group Description	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
Overall Participants	28
Age (Count of Participants)
<=18 years	28 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	10 35.7%
Male	18 64.3%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Urodynamics Arm
Arm/Group Description	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
Measure Participants	28
Count of Participants [Participants]	28 100%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Urodynamics Arm
Arm/Group Description	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
Measure Participants	28
Count of Participants [Participants]	28 100%

Adverse Events

Time Frame	Through study completion, an average of 5 to 7 days
Arm/Group Title	Urodynamics Arm
Arm/Group Description	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
All Cause Mortality
	Urodynamics Arm
	Affected / at Risk (%)	# Events
Total	0/28 (0%)
Serious Adverse Events
	Urodynamics Arm
	Affected / at Risk (%)	# Events
Total	0/28 (0%)
Other (Not Including Serious) Adverse Events
	Urodynamics Arm
	Affected / at Risk (%)	# Events
Total	4/28 (14.3%)
Gastrointestinal disorders
Hematochezia	1/28 (3.6%)	1
Renal and urinary disorders
Dysuria	3/28 (10.7%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.