Electronic Catheter Stethoscope

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of South Florida
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01463462
First received: October 19, 2011
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: February 2011
Groups/Cohorts
Electronic Catheter Stethoscope

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463462

Contacts
Contact: Ashley Cain, MD 813-259-8680 ObGynClinicalResearch@health.usf.edu
Contact: Caroline Young, MSN ARNP 813-259-8680 ObGynClinicalResearch@health.usf.edu

Locations
United States, Florida
Women's Center Operating Rooms at the Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Caroline Young, MSN ARNP    813-259-8680    ObGynClinicalResearch@health.usf.edu   
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Stuart Hart, MD University of South Florida
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01463462     History of Changes
Other Study ID Numbers: USF IRB 00001841
Study First Received: October 19, 2011
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 20, 2014