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Electronic Catheter Stethoscope

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ClinicalTrials.gov Identifier: NCT01463462
Recruitment Status : Completed
First Posted : November 2, 2011
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
University of South Florida

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.

Condition or disease
Pelvic Organ Prolapse Gynecologic Cancers Uterine Leiomyomata Adenomyosis Endometrial Hyperplasia Other Abnormal Uterine and Vaginal Bleeding Pelvic Mass Pelvic Pain

Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of the Electronic Catheter Stethoscope for the Detection of Urinary Tract Injury During Gynecologic Surgery
Study Start Date : February 2011
Primary Completion Date : April 2016
Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Electronic Catheter Stethoscope



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Current patients having gynecological surgery
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463462


Locations
United States, Florida
Women's Center Operating Rooms at the Tampa General Hospital
Tampa, Florida, United States, 33606
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Stuart Hart, MD University of South Florida

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01463462     History of Changes
Other Study ID Numbers: USF IRB 00001841
First Posted: November 2, 2011    Key Record Dates
Last Update Posted: May 27, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Hyperplasia
Prolapse
Pelvic Organ Prolapse
Pelvic Pain
Leiomyoma
Adenomyosis
Myofibroma
Endometrial Hyperplasia
Uterine Hemorrhage
Pathologic Processes
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Signs and Symptoms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Connective Tissue
Connective Tissue Diseases
Hemorrhage