T-DOC® NXT Clinical Investigation

Laborie Medical Technologies Inc.20 enrolled

Overview

Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Incontinence, Urge

Interventions

TDOC NXTDEVICE

Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male and Female (Adult age 21+) * Patients with clinical indication for urodynamics (UDS) testing, for any medically necessary reason as per the physician. Exclusion Criteria: * Patients who suffer from bladder infections (not including patients with asymptomatic bacteriuria) * Patients who are pregnant * Patients with recent (less than 2 weeks) pelvic floor surgery * Patients who require the use of a suprapubic catheter * Patients with significant cognitive deficiency that prevent the patient from giving informed consent

Locations (1)

Franklin Square Hospital/White Marsh

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

The Number of Patients in Which the T-DOC® NXT Catheters Are Safe in Measuring Urodynamic Pressure in Adults.

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 20 patient questionnaires is required to answer "YES" the device is safe for a positive outcome and a maximum of 40.

Time frame: 2 months

The Number of Patients in Which the T-DOC® NXT Catheters Are Effective in Measuring Urodynamic Pressure in Adults.

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 20 patient questionnaires is required to answer "YES" the device is effective for a positive outcome and a maximum of 40.

Time frame: 2 months

Data from ClinicalTrials.gov

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