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

Worthington-Kirsch, Robert L., M.D.

Status and phase

Completed

Phase 1

Conditions

Leiomyomatosis

Uterine Neoplasms

Leiomyoma

Treatments

Device: Uterine fibroid embolization BeadBlock™

Device: Uterine fibroid embolization Embosphere®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00361036

G060030

Details and patient eligibility

About

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.

Full description

The purpose of the study is to conduct a comparison between BeadBlock™ and Embosphere in uterine fibroid embolization. Baseline and follow-up MR Imaging data will be made with respect to changes in fibroid and uterus perfusion and fibroid and uterine volume. This is a 12 months study (12 month follow up for all enrollees). The primary end-point will be the degree of fibroid devascularization as seen at contrast-enhanced MRI performed 3 months (+/- 15 days) after UAE procedure. In addition we will assess symptom reduction in patients that have undergone uterine fibroid embolization with Bead Block™ and Embosphere®.

Primary Objective 1. To assess the change in fibroid devascularization as seen at contrast-enhanced MRI performed after UAE and at three (3) months (+/- 15 days) following the UAE, and compare the changes between BeadBlock™ and Embosphere.

Secondary Objective

To assess the change in fibroid devascularization as seen at contrast-enhanced MRI performed several days after UAE and 6 months (+/- 15 days) following the UAE, and compare the changes between BeadBlock™ and Embosphere.

Tertiary Objective

To assess the change in uterine volume as seen at contrast-enhanced MRI performed several days after UAE, 3 months (+/- 15 days) and 6 months (+/- 15 days) following the UAE, and compare the changes between BeadBlock™ and Embosphere.
To assess the change from baseline in symptom severity (UFS-QOL)at 3, 6 and 12 months (+/- 15 days) follow-up, as measured by the subscale of the UFS questionnaire, and compare the changes between BeadBlock™ and Embosphere.

Enrollment

44 patients

Sex

Female

Ages

30 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.