NL-OMON29773CompletedNot Applicable
EW SPERE: Uterine Fibroid Embolization (UFE) Study Using Newly Designed Embozene Microspheres - UFE (Uterine Fibroid Embolization)
CeloNova BioSciences0 sites6 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 6
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •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
Investigators
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