Electronic Catheter Stethoscope

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Electronic Catheter Stethoscope

No interventions assigned to this group

Eligibility Criteria

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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