Clinical trial · Observational
Electronic Catheter Stethoscope
Use of the Electronic Catheter Stethoscope for the Detection of Urinary Tract Injury During Gynecologic Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomyosis | — | UNRESOLVED | — |
| Endometrial Hyperplasia | — | UNRESOLVED | — |
| Gynecologic Cancers | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Other Abnormal Uterine and Vaginal Bleeding | — | UNRESOLVED | — |
| Pelvic Mass | — | UNRESOLVED | — |
| Pelvic Organ Prolapse | — | UNRESOLVED | — |
| Pelvic Pain | — | UNRESOLVED | — |
| Uterine Leiomyomata | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Electronic Catheter Stethoscope
Primary outcomes (1)
- measure
- bladder and ureter sounds during pelvic surgery.
- timeFrame
- from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours)
Secondary outcomes (1)
- measure
- changes from baseline bladder and ureteral function sounds
- timeFrame
- from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available