Tetra-NIRS Clinical Study

Stopped early · Phase 4

Conditions studied: Lower Urinary Tract Symptoms, Overactive Bladder

In brief

The purpose of this evaluation is to validate the previous clinical study results using a Near-Infrared Spectroscopy (NIRS) device, as compared to the conventional urodynamics (UDS) testing. The experiment will use the commercially available Tetra-NIRS and Laborie UDS equipment. The hypothesis is that the Tetra-NIRS device, in the clinical environment, provides data to enhance the analysis using the standard urodynamics equipment (stand-alone Urodynamic procedure).

Key facts

Study ID

NCT00871975

Run by

Laborie Medical Technologies Inc.

People needed

155

Starts

2009-04-01

Expected to finish

2012-02-01

Last updated by the study team

2016-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The selection of subjects enrolled for testing must meet the following criteria:
• Subjects must be 18 years of age or older.
• Subjects are patients of one of the institutions and are currently scheduled for UDS
• Male subjects must have LUTS
• Female subjects must have OAB
• Subjects must give their informed consent prior to enrolment.

You may not qualify if…

• The patient has an existing health condition which the investigators feel will not allow for safe or accurate measurements with the Tetra-NIRS device.

Where it is running

• Vanderbilt University — Nashville, Tennessee, United States
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• King's College Hospital NHS Foundation Trust — London, United Kingdom

Full record on ClinicalTrials.gov

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