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T-DOC® 5 Fr Pediatric Clinical Investigation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03429270
Recruitment Status : Completed
First Posted : February 12, 2018
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Laborie Medical Technologies Inc.

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
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 : January 22, 2018
Actual Primary Completion Date : October 17, 2018
Actual Study Completion Date : October 17, 2018

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




Primary Outcome Measures :
  1. Recording the number of patients undergoing the urodynamic procedure to assess the safety of the T-DOC® 5 Fr vesical and abdominal catheter, used in pediatric subjects during urodynamic investigations. [ Time Frame: 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. Recording the number of patients undergoing the urodynamic procedure to asses the efficacy of the T-DOC® 5 Fr vesical and abdominal catheter, used in pediatric subjects during urodynamic investigations. [ Time Frame: 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.



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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female and male pediatric
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429270


Locations
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United States, Virginia
University of Virginia Health System - UVA - Pediatric Urology Clinic
Charlottesville, Virginia, United States, 22903
J.W. Ruby Memorial Hospital and WVU Medicine Children's
Morgantown, Virginia, United States, 26506
Sponsors and Collaborators
Laborie Medical Technologies Inc.

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Responsible Party: Laborie Medical Technologies Inc.
ClinicalTrials.gov Identifier: NCT03429270     History of Changes
Other Study ID Numbers: TDOC5Fr-PEDS-01-PR
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Urinary Incontinence, Urge
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms