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UnknownNCT00351494

Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization

Status
Unknown
Phase
Study type
Observational
Enrollment
40 (estimated)
Sponsor
University Hospital, Tours · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREcontrast enhanced ultrasonographyThree contrast-enhanced ultrasonography : before embolization, after one day and after 6 months. Abdominal route 2.4 ml sonovue per injection / bolus
PROCEDUREembolizationIntervention is described in the case report form for each patient

Timeline

Start date
2006-07-01
Completion
2009-06-01
First posted
2006-07-13
Last updated
2007-11-22

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT00351494. Inclusion in this directory is not an endorsement.

Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization (NCT00351494) · Clinical Trials Directory