Uretal Flow Assessment During Gynecological Procedures

• Sponsor: Ethicon, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00453882
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• 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: Nov 1, 2006
• Actual Primary Completion Date: Apr 1, 2007
• Actual Study Completion Date: Apr 1, 2007

Outcome Measures

Primary Outcome Measures

1. Ability to evaluate ureteric jets []

2. Adverse events []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Holy Cross Medical Group	Fort Lauderdale	Florida	United States	33308

Sponsors and Collaborators

• Ethicon, Inc.

Investigators

• Study Director: David Robinson, MD, Ethicon, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ethicon, Inc.
• ClinicalTrials.gov Identifier: NCT00453882
• Other Study ID Numbers: 300-06-003
• First Posted: Mar 29, 2007
• Last Update Posted: Jan 30, 2012
• Last Verified: Jan 1, 2012

Study Results

No Results Posted as of Jan 30, 2012