NCT00453882CompletedNot Applicable
An Evaluation of Ureteral Flow After Temporary Bilateral Uterine Artery Occlusion During Conservative Gynecological Procedures
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ethicon, Inc.
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Ability to evaluate ureteric jets
Study Overview
Brief Summary
The objective is to evaluate the feasibility of using color Doppler ultrasound in ureteral flow assessment after uterine artery occlusion during a conservative gynecological procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Meets criteria for conservative gynecological procedure
- •At least 25 years of age
- •Cervix suitable for tenaculum placement
- •Provides written informed consent.
Exclusion Criteria
- •Pregnancy
- •One or more lower uterine segment fibroids
- •Hydronephrosis as determined by renal ultrasound pre-procedurally
- •Clinical diagnosis of urinary tract infection (UTI)
- •In the medical judgment of the physician, such a procedure may compromise the patient's condition
- •Inability to achieve bilateral occlusion with the clamp placement during the procedure.
Outcomes
Primary Outcomes
Ability to evaluate ureteric jets
Adverse events
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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