Uretal Flow Assessment During Gynecological Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00453882
Recruitment Status : Completed
First Posted : March 29, 2007
Last Update Posted : January 30, 2012
Information provided by (Responsible Party):
Ethicon, Inc.

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.

Condition or disease Intervention/treatment Phase
Conservative Gynecological Procedures Device: flostat (TM) System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Evaluation of Ureteral Flow After Temporary Bilateral Uterine Artery Occlusion During Conservative Gynecological Procedures
Study Start Date : November 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Primary Outcome Measures :
  1. Ability to evaluate ureteric jets
  2. Adverse events

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00453882

United States, Florida
Holy Cross Medical Group
Fort Lauderdale, Florida, United States, 33308
Sponsors and Collaborators
Ethicon, Inc.
Study Director: David Robinson, MD Ethicon, Inc.

Responsible Party: Ethicon, Inc. Identifier: NCT00453882     History of Changes
Other Study ID Numbers: 300-06-003
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: January 30, 2012
Last Verified: January 2012