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Electronic Catheter Stethoscope

NCT01463462 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2016-05-27

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

Principal Investigators

  • Stuart Hart, MD · University of South Florida

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01463462 on ClinicalTrials.gov