Electronic Catheter Stethoscope

NCT01463462 | Completed DMC

• 1 other identifier: USF IRB 00001841
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (1)

Electronic Catheter Stethoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Current patients having gynecological surgery

You may qualify if:

• 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

You may not qualify if:

• under 18 years of age
• bilateral tubal ligation as the single reason for surgery
• current pregnancy
• unable to provide written informed consent

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Women's Center Operating Rooms at the Tampa General Hospital

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Myofibroma; Adenomyosis; Endometrial Hyperplasia; Uterine Hemorrhage; Pelvic Pain

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Stuart Hart, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: November 2, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 27, 2016

Record last verified: 2016-05

Locations

US (1)