Spots Global Cancer Trial Database for Electronic Catheter Stethoscope
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Trial Identification
Brief Title: Electronic Catheter Stethoscope
Official Title: Use of the Electronic Catheter Stethoscope for the Detection of Urinary Tract Injury During Gynecologic Surgery
Study ID: NCT01463462
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Women's Center Operating Rooms at the Tampa General Hospital, Tampa, Florida, United States
Contact Details
Name: Stuart Hart, MD
Affiliation: University of South Florida
Role: PRINCIPAL_INVESTIGATOR
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