EW SPERE: Uterine Fibroid Embolization (UFE) Study Using Newly Designed Embozene Microspheres

Completed

Conditions: Uterine Fibroids
10013326

Registration Number: NL-OMON29773

Lead Sponsor: CeloNova BioSciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Clinical succes(6 month)<br /><br>1. Fibroid-related menorrhagia<br /><br>2. Pain and discomfort<br /><br>3. Overall health<br /><br>Procedure safety:<br /><br>4. Serious adverse events and complications</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Morphology and outcome:<br /><br>1. Size of uterus<br /><br>2. Size of dominant fibroid<br /><br>3. Hospitalization time<br /><br>4. Time to return to normal activities</p><br>