Electronic Catheter Stethoscope
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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 |
- 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 ]
- 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 |
Current patients having gynecological surgery
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| Contact: Alyssa Cobb, BA, BS | 813-259-8680 | ObGynClinicalResearch@health.usf.edu |
| Contact: Caroline Young, MSN ARNP | 813-259-8680 | ObGynClinicalResearch@health.usf.edu |
| 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 | |
| Principal Investigator: | Stuart Hart, MD | University of South Florida |
More Information
Additional 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: | January 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Endometrial Hyperplasia Hemorrhage Hyperplasia Leiomyoma Myofibroma Pelvic Pain Prolapse Uterine Hemorrhage Adenoma Pelvic Organ Prolapse Uterine Diseases Genital Diseases, Female |
Pathologic Processes Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases Pain Signs and Symptoms Pathological Conditions, Anatomical Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on May 19, 2013