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OpenTrials
Completed

NCT Number: NCT00453882

Uretal Flow Assessment During Gynecological Procedures

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.

Completed

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Key information

Conditions

Conservative Gynecological Procedures

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Holy Cross Medical Group

Fort Lauderdale, Florida, 33308, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

flostat (TM) System

Device

Primary outcomes

  1. Ability to evaluate ureteric jets

  2. Adverse events

Sponsors and collaborators

Lead sponsor

Ethicon, Inc.

Industry

Registry information

Official study title

An Evaluation of Ureteral Flow After Temporary Bilateral Uterine Artery Occlusion During Conservative Gynecological Procedures

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 29, 2007
Registry last updated
Jan 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.