Status:
TERMINATED
Tetra-NIRS Clinical Study
Lead Sponsor:
Laborie Medical Technologies Inc.
Conditions:
Lower Urinary Tract Symptoms
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 exper...
Detailed Description
This is a study of the commercially available Tetra-NIRS device to compare the results collected against conventional urodynamics. The study will evaluate male patients with lower urinary tract sympto...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- The patient has an existing health condition which the investigators feel will not allow for safe or accurate measurements with the Tetra-NIRS device.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00871975
Start Date
April 1 2009
End Date
February 1 2012
Last Update
July 19 2016
Active Locations (3)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37232
2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
3
King's College Hospital NHS Foundation Trust
London, United Kingdom