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Uretal Flow Assessment During Gynecological Procedures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00453882
First Posted: March 29, 2007
Last Update Posted: January 30, 2012
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.
Information provided by (Responsible Party):
Ethicon, Inc.
  Purpose
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 Intervention
Conservative Gynecological Procedures Device: flostat (TM) System

Study Type: Interventional
Study Design: 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

Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • Ability to evaluate ureteric jets
  • Adverse events

Enrollment: 7
Study Start Date: November 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00453882


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

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00453882     History of Changes
Other Study ID Numbers: 300-06-003
First Submitted: March 28, 2007
First Posted: March 29, 2007
Last Update Posted: January 30, 2012
Last Verified: January 2012