Electronic Catheter Stethoscope

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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