Electronic Catheter Stethoscope

Use of the Electronic Catheter Stethoscope for the Detection of Urinary Tract Injury During Gynecologic Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01463462

Enrollment

Registered

2011-11-02

Start date

2011-02-28

Completion date

2016-04-30

Last updated

2016-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
bladder and ureter sounds during pelvic surgery.	from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours)

Secondary

Measure	Time frame
changes from baseline bladder and ureteral function sounds	from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours)

Countries

United States

Outcome results