Trials / Completed
CompletedNCT01463462
Electronic Catheter Stethoscope
Use of the Electronic Catheter Stethoscope for the Detection of Urinary Tract Injury During Gynecologic Surgery
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 75 (actual)
- Sponsor
- University of South Florida · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Pelvic Organ Prolapse
- Gynecologic Cancers
- Uterine Leiomyomata
- Adenomyosis
- Endometrial Hyperplasia
- Other Abnormal Uterine and Vaginal Bleeding
- Pelvic Mass
- Pelvic Pain
Timeline
- Start date
- 2011-02-01
- Primary completion
- 2016-04-01
- Completion
- 2016-04-01
- First posted
- 2011-11-02
- Last updated
- 2016-05-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01463462. Inclusion in this directory is not an endorsement.