Uretal Flow Assessment During Gynecological Procedures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00453882
First received: March 28, 2007
Last updated: January 26, 2012
Last verified: January 2012
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   25 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00453882     History of Changes
Other Study ID Numbers: 300-06-003
Study First Received: March 28, 2007
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 14, 2014