A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)

2014-08-27 03:32:26 | BioPortfolio


The purpose of this study is to demonstrate comparability between Contour SE™ Microspheres and Embosphere® Microspheres for achieving post UFE fibroid devascularization in women with symptomatic uterine fibroids.


The purpose of this prospective randomized single-center study is to demonstrate comparability using Contour SE™ Microspheres (700-900µ and 900-1200µ) using a near stasis endpoint and Embosphere® Microspheres (500-700µ) using a "prune tree" endpoint for achieving post UFE fibroid devascularization in women with symptomatic uterine fibroids. The study will demonstrate (with the use of contrast enhanced Magnetic Resonance Imaging (MRI) at baseline and 24-hours post embolization) that uterine fibroids can successfully be devascularized using the embolization protocols. Contrast enhanced MRI will be performed at baseline, 24-hours, and 3-months post UFE. The subjects will be followed through 12-months post UFE and change from baseline in symptom severity (Quality of Life (QoL) Questionnaire) will be assessed at 3 months and 12 months.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment




Uterine Fibroid Embolization (UFE), Contour SE™ Microspheres, Embosphere® Microspheres


Hospital of the University of Pennsylvania
United States




Boston Scientific Corporation

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:32:26-0400

Clinical Trials [340 Associated Clinical Trials listed on BioPortfolio]

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

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 wi...

Analysis of Prostatic Arterial Embolization for Benign Prostatic Hyperplasia Using Embosphere Microspheres

Investigators hypothesis that arterial embolization of men with symptomatic BPH, analogous to uterine fibroid embolization for women, is safe and effective.

Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)

This is a prospective, open label single center feasibility study to demonstrate basic safety and effectiveness of prostate artery embolization for the treatment of symptomatic benign pros...

Quality of Life in Patients Undergoing Embolization Using Yttrium Y 90 Glass Microspheres for Primary or Metastatic Liver Cancer

RATIONALE: Learning about quality of life in patients with cancer undergoing embolization may help doctors learn about the side effects of treatment and plan the best treatment. PURPOSE: ...

A Multicenter Prospective Non-Interventional Study Assessing the Management of Canadian Women With Uterine Fibroids

This study will characterize the treatments and outcomes associated with different uterine fibroid treatments in Canada, to understand patients' preferences and satisfaction with different...

PubMed Articles [1127 Associated PubMed Articles listed on BioPortfolio]

Practical Tantalum Coating of Microspheres for Experimental Visualization under Fluoroscopy and CT.

The present report describes a simple technique for tantalum coating of microspheres for visualization by fluoroscopy and computed tomography (CT). Spherical microspheres were soaked with Ta powder un...

Synthesis and characterization of multifunctional magnetic polyvinyl alcohol (PVA) microspheres for embolization of blood vessel.

Vascular embolization has exhibited increasing significance in treatment of terminal cancer. In order to achieve better embolic effects, magnetic PVA (polyvinyl alcohol) hydrogel microspheres were syn...

Direct preparation of La2Zr2O7 microspheres by cathode plasma electrolysis.

La2Zr2O7 microspheres were directly prepared by cathode plasma electrolysis (CPE) in the electrolyte of Zr(NO3)4·5H2O and La(NO3)3·6H2O. Compared with high temperature sintering methods, the energy ...

Literature review of outcomes and prevalence and case report of leiomyosarcomas and non-typical uterine smooth muscle leiomyoma tumors treated with uterine artery embolization.

To describe the early and late outcomes of uterine smooth muscle tumors that are either malignant or have the potential for recurrence (MRUSMTs) after uterine artery embolization (UAE).

Rare gynaecological emergency: massive intraperitoneal haemorrhage from spontaneous rupture of a superficial vessel on a large leiomyoma.

Uterine leiomyomas rarely present as gynaecological emergencies. We report a case of a 29-year-old nulliparous woman, with a negative pregnancy test, who presented with collapse and an admission haemo...

Medical and Biotech [MESH] Definitions

The use of embolizing agents to block the arterial blood supply to parts or all of the UTERUS. The procedures are done to control bleeding or to cause destruction of uterine tissues.

Small uniformly-sized spherical particles, of micrometer dimensions, frequently labeled with radioisotopes or various reagents acting as tags or markers.

A biocompatible, hydrophilic, inert gel that is permeable to tissue fluids. It is used as an embedding medium for microscopy, as a coating for implants and prostheses, for contact lenses, as microspheres in adsorption research, etc.

Iron (II,III) oxide (Fe3O4). It is a black ore of IRON that forms opaque crystals and exerts strong magnetism. The NANOPARTICLES; and MICROSPHERES of its mineral form, magnetite, have many biomedical applications.

A benign tumor derived from smooth muscle tissue, also known as a fibroid tumor. They rarely occur outside of the UTERUS and the GASTROINTESTINAL TRACT but can occur in the SKIN and SUBCUTANEOUS TISSUE, probably arising from the smooth muscle of small blood vessels in these tissues.

More From BioPortfolio on "A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)"

Quick Search

Relevant Topic

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Searches Linking to this Trial