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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014