Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Electronic Catheter Stethoscope

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01463462
First received: October 19, 2011
Last updated: May 26, 2016
Last verified: May 2016

October 19, 2011
May 26, 2016
February 2011
April 2016   (Final data collection date for primary outcome measure)
bladder and ureter sounds during pelvic surgery. [ Time Frame: from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours) ]
Same as current
Complete list of historical versions of study NCT01463462 on ClinicalTrials.gov Archive Site
changes from baseline bladder and ureteral function sounds [ Time Frame: from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours) ]
Same as current
Not Provided
Not Provided
 
Electronic Catheter Stethoscope
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Current patients having gynecological surgery
  • Pelvic Organ Prolapse
  • Gynecologic Cancers
  • Uterine Leiomyomata
  • Adenomyosis
  • Endometrial Hyperplasia
  • Other Abnormal Uterine and Vaginal Bleeding
  • Pelvic Mass
  • Pelvic Pain
Not Provided
Electronic Catheter Stethoscope
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
April 2016
April 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01463462
USF IRB 00001841
Yes
Not Provided
Not Provided
Not Provided
University of South Florida
University of South Florida
Not Provided
Principal Investigator: Stuart Hart, MD University of South Florida
University of South Florida
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP