Uro-NIRS Clinical Study
Completed · Not applicable
Conditions studied: Lower Urinary Tract Symptoms, Overactive Bladder
In brief
The purpose of this experiment is to confirm the results of previous testing of Urodynamix's Uro-NIRS device. Together Urodynamix and Laborie have created a device that includes standard Laborie medical equipment and the experimental Urodynamix device. Collectively this integrated device is considered an investigational device, and the results from this study may be used to support a submission to the US Food and Drug Administration for the approval of the integrated device. This research is being done because we want to test the ability of the integrated Laborie and Urodynamix device to provide a non-invasive method to provide additional information to assist with the diagnosis of or treatment plan of patients suffering from urinary problems. The current technologies rely solely on the measurement of internal pressures of the bladder, which involves the insertion of catheter into the subject's urethra.
Key facts
- Study ID
- NCT00706407
- Run by
- Weill Medical College of Cornell University
- People needed
- 42
- Starts
- 2008-04-01
- Expected to finish
- 2010-05-01
- Last updated by the study team
- 2018-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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 enrollment.
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 Uro-NIRS:UDS device.
Where it is running
- New York-Presbyterian Hospital Weill Cornell Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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