Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlock™ Embolic Agent

Completed · Phase 1

Conditions studied: Leiomyoma, Leiomyomatosis, Uterine Neoplasms

In brief

A double arm (non-inferiority) 44 patient study to assess the performance of BeadBlock™ in the treatment of uterine fibroids by embolization with respect to clinical \& imaging outcome with comparison of primary safety endpoints to Embosphere.

Key facts

Study ID: NCT00361036
Run by: Worthington-Kirsch, Robert L., M.D.
People needed: 44
Starts: 2006-08-01
Expected to finish: 2010-03-01
Last updated by the study team: 2011-04-18

Who can join

Age: 30 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Patient chooses to participate and has signed informed consent
Age between 30 and 50 years old
Symptoms caused by uterine fibroids, such as heavy bleeding (menorrhagia) and/or bulk-related complaints such as urinary frequency, constipation or pelvic pain.
Patient has fibroids confirmed by MRI
Patient has normal kidney function.
Patient is willing and able to undergo follow-up imaging at 3 and 6 months post UFE.

You may not qualify if…

Patients who are pregnant or plan to become pregnant within the study period, or desire future fertility.
Patients with a history of gynecologic malignancy
Patients with known endometrial hyperplasia
Patients with adenomyosis
Patients with pelvic inflammatory disease
Patients with Uteri < 250 ml (cm) calculated volume or > 24 weeks
Patients with pedunculated subserosal fibroids with a narrow attachment (<50% diameter of the fibroid) to the uterus.
Patients with pelvic pain as dominant syndrome
Known allergy to contrast media that cannot be adequately pre-medicated.
Patients not suitable for arterial access.
Previous uterine artery embolization attempts.
History of pelvic irradiation.
Patients on GnRH Therapy within 3-6 months prior to the study enrollment.

Where it is running

Albany Medical Center — Albany, New York, United States
Image Guided Surgery Associates — Pottstown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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