An observational study in Myoma, sponsored by University Hospital, Tours. Status unknown at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-11-22.
Sponsored by University Hospital, Tours · Observational
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.
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.
61 studies on the registry are indexed under Myoma; 10 are open to participants now.
This study's planned enrollment of 40 is below the median of 111 across 13 observational studies indexed under Myoma.
Browse Myoma studies →University Hospital, Tours is the lead sponsor of 307 studies on the registry; 79 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women candidate for embolization of myomas
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Three contrast-enhanced ultrasonography : before embolization, after one day and after 6 months. Abdominal route 2.4 ml sonovue per injection / bolus
Intervention is described in the case report form for each patient
To investigate the usefulness of contrast-enhanced ultrasound with real-time imaging technique in the assessment of vascular patterns from myomas myometrium and ovaries before and after uterine artery embolization
Time frame: Inclusion period and follow-up
Accordance between contrast-enhanced imaging and IRM
Time frame: inclusion period and follow-up
Accordance between early vascular patterns due to embolization of the fibroma and the success of the technique which is evaluated after 6 month
Time frame: inclusion period and follow-up
Relationship between the post embolization pain and the vascular change of the fibroma and the myometrium
Time frame: inclusion period
The record gives a start of Jul 2006 and a completion of Jun 2009. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.
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