Viewing Study NCT00351494


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Study NCT ID: NCT00351494
Status: UNKNOWN
Last Update Posted: 2007-11-22
First Post: 2006-07-12
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization
Sponsor: University Hospital, Tours
Organization:

Study Overview

Official Title: Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization
Status: UNKNOWN
Status Verified Date: 2007-11
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Contrast-enhanced ultrasound is supposed to improve the detection of myomas as well as improve the follow-up after specific treatments like embolization. It will also help the investigators better understand the mechanism of success or failure for embolization and could reduce the amount of particles injected by determining the endpoint of the procedure in order to treat the myomas while preserving the myometrium.
Detailed Description: Before embolization of the uterine artery, 40 patients with unique or multiple myomas will be included prospectively in our study and evaluated with sonography before and after injection of Sonovue (2.4 ml) (Bracco Int Milano Italy). Pelvic ultrasound with contrast enhancement will be done the day after and six months after the procedure.

Microvascularization of the myomas and the endometrium will be described. Some tiny myomas which are not visible on conventional sonography could be identified for a perfect matching with MRI detection.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: