T-DOC® 5 Fr Pediatric Clinical Investigation

Laborie Medical Technologies

Status: Completed

Conditions: Incontinence, Urge

Treatments: Device: TDOC 5Fr

Study type: Interventional

Funder types: Industry

Identifiers

NCT03429270

TDOC5Fr-PEDS-01-PR

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: Under 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Urodynamics Arm

Experimental group

Treatment:

Device: TDOC 5Fr