Uterine Fibroids
Conditions
Interventions
Embozene microsferes injection in the uterine arteries
Sponsors
CeloNova BioSciences
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical succes(6 month) 1. Fibroid-related menorrhagia 2. Pain and discomfort 3. Overall health Procedure safety: 4. Serious adverse events and complications | — |
Secondary
| Measure | Time frame |
|---|---|
| Morphology and outcome: 1. Size of uterus 2. Size of dominant fibroid 3. Hospitalization time 4. Time to return to normal activities | — |
Countries
Netherlands
Outcome results
None listed