To provide clinical data on clinical efficacy to support embolisation of uterine fibroids using Embozene microsferes
ID
Source
Brief title
Condition
- Menstrual cycle and uterine bleeding disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical succes(6 month)
1. Fibroid-related menorrhagia
2. Pain and discomfort
3. Overall health
Procedure safety:
4. Serious adverse events and complications
Secondary outcome
Morphology and outcome:
1. Size of uterus
2. Size of dominant fibroid
3. Hospitalization time
4. Time to return to normal activities
Background summary
Uterine artery embolisation for symptomatic fibroids is currently a standard
routine procedure in our hospital. The embolic agent embozen microsferes is an
alternetive for the currently used microsferes and the issue of the study is to
do a post CE approval investigation on their use in the dedicated uterine
fibroid population.
Study objective
To provide clinical data on clinical efficacy to support embolisation of
uterine fibroids using Embozene microsferes
Study design
prospective non-randomized multi-centre study
Intervention
Embozene microsferes injection in the uterine arteries
Study burden and risks
No additional burden and risks correlated to the routine embolisation procedure
49 Spring Street
Newnan, Georgia 30263
USA
49 Spring Street
Newnan, Georgia 30263
USA
Listed location countries
Age
Inclusion criteria
Age between 25 and menopause
No intention to become pregnant within the two years following treatment
One or more uterine fibroids
Abnormal vaginal bleeding, abnormal menstrual pain or abnormal pelvic pain, as defined and document by the study CRF
Willing and able to sign the informed consent form
Exclusion criteria
Pregnant
Pelvic inflammatory disease
presence of one or more submucosal fibroids with more than 50% growth into the uterine cavity
Presence of pedunculated serosal fibroids as the dominant fibroid
Uterine fibroid with significant collateral feeding by vessels other than the uterine arteries
Adenomyosis as the dominant cause of the clinical symptoms
Endometrial neoplasia or pre-malignant hyperplasia
Any malignancy of the pelvic region
Any active infection of the pelvic region
Known allergy to IV contrast material
Blood coagulation disorder that would prohibit arterial puncture
Immunocompromized women
Post-menopausal or FSH> 40 mIU/mL
Hormonal treatment within the previous three month
Unwilling or unable to sign the informed consent formor to adhere to the study requirements, including completion of menstruyal bleeding records and follow-up visits
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL11825.008.06 |