Brief Title
Electronic Catheter Stethoscope
Official Title
Use of the Electronic Catheter Stethoscope for the Detection of Urinary Tract Injury During Gynecologic Surgery
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.
Study Type
Observational
Primary Outcome
bladder and ureter sounds during pelvic surgery.
Secondary Outcome
changes from baseline bladder and ureteral function sounds
Condition
Pelvic Organ Prolapse
Study Arms / Comparison Groups
Electronic Catheter Stethoscope
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
75
Start Date
February 2011
Completion Date
April 2016
Primary Completion Date
April 2016
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Stuart Hart, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01463462
Organization ID
USF IRB 00001841
Responsible Party
Sponsor
Study Sponsor
University of South Florida
Study Sponsor
Stuart Hart, MD, Principal Investigator, University of South Florida
Verification Date
May 2016