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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00351494
Date of registration: 12/07/2006
Primary sponsor: University Hospital, Tours
Public title: Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization
Scientific title: Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization
Date of first enrolment: July 2006
Target sample size: 40
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT00351494
Study type:  Observational
Study design:  Time Perspective: Prospective  
Countries of recruitment
France
Contacts
Name:   Henri MARRET, Pr
Address: 
Telephone: (33) 2 47 47 82 59
Email: marret@med.univ-tours.fr
Affiliation: 
Name:   Henri MARRET, Pr
Address: 
Telephone: (33) 2 47 47 82 59
Email: marret@med.univ-tours.fr
Affiliation: 
Name:   François TRANQUART, Pr
Address: 
Telephone:
Email:
Affiliation:  Centre d'Innovation Technologique CHRU TOURS
Name:   Henri MARRET, Pr
Address: 
Telephone:
Email:
Affiliation:  Service de Gynécologie Obstétrique CHRU TOURS
Key inclusion & exclusion criteria

Inclusion Criteria:

- Uterine myomas with solid tissue (greater diameter lower than 15 cm)

- The embolization is planified during the 15 days after the contrast ultrasonography

- Written informed consent is signed

Exclusion Criteria:

- Intracavitary uterine mass possibly due to a polyp or endometrial cancer

- Necessity of using the endovaginal way of ultrasonography because of the myoma's size
and accessibility

- Menopause

- Pregnancy and breastfeeding

- Recent cardiac affection

- History of acute cardiac disease



Age minimum: 18 Years
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Myoma
Intervention(s)
Procedure: contrast enhanced ultrasonography
Procedure: embolization
Primary Outcome(s)
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]
Secondary Outcome(s)
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]
Secondary ID(s)
HP06-HM/FIBROME
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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