Electronic Catheter Stethoscope



Status:Completed
Conditions:Cervical Cancer, Cancer, Women's Studies, Hematology
Therapuetic Areas:Hematology, Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:5/28/2016
Start Date:February 2011
End Date:April 2016

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Use of the Electronic Catheter Stethoscope for the Detection of Urinary Tract Injury During Gynecologic Surgery

This is an observational, exploratory study designed to collect (record) and analyze normal
and abnormal sound data from the human bladder during surgery using a novel sensor-based
catheter system (Electronic Catheter Stethoscope) and to develop algorithms to detect
changes of baseline bladder and ureteral function. The Electronic Catheter Stethoscope
device will measure acoustic and pressure data within the bladder. The measurements will be
used to detect any leakage from the bladder and/or changes in baseline ureteral flow by
correlation of sound data with surgical data reported by the surgeon. These data will be
used to develop algorithms to detect changes of baseline bladder and ureteral function. The
algorithms will be tested in future clinical trials.


Inclusion Criteria

- age 18 or older

- plan to have one of the following types of surgery:

- laparoscopic or abdominal gynecological surgery

- vaginal surgery

- able to provide written informed consent

Exclusion Criteria

- under 18 years of age

- bilateral tubal ligation as the single reason for surgery

- current pregnancy

- unable to provide written informed consent
We found this trial at
1
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Tampa, FL
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