A Prospective Study Comparing Contour SEâ„¢ Microspheres to EmbosphereÂ® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
The purpose of this study is to demonstrate comparability between Contour SEâ„˘ Microspheres and EmbosphereÂ® 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 SEâ„˘ Microspheres (700-900Âµ and 900-1200Âµ) using a near stasis endpoint and EmbosphereÂ® Microspheres (500-700Âµ) 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Uterine Fibroid Embolization (UFE), Contour SEâ„˘ Microspheres, EmbosphereÂ® Microspheres
Hospital of the University of Pennsylvania
Boston Scientific Corporation
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00628901
- Information obtained from ClinicalTrials.gov on September 18, 2011
A double arm (non-inferiority) 44 patient study to assess the performance of BeadBlockâ„˘ in the treatment of uterine fibroids by embolization with respect to clinical & imaging outcome wi...
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: ...
The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment. Indications for use for this system is: 'The ExAblate is intende...
The study is designed to determine whether loading doxorubicin (a type of chemotherapy), when loaded onto a drug eluting microsphere will result in increased destruction of a tumor. The s...
Uterine leiomyomas are the leading cause of hysterectomy in the United States, accounting for over 200,000 procedures each year. Most epidemiologic studies of uterine leiomyoma show that ...
To compare the effect of two alternative treatment options for uterine fibroids: ulipristal acetate (UPA) and uterine artery embolization (UAE) on fibroid volume and vascularity at 3 month follow-up.
The use of laparoscopic myomectomy as a surgical treatment for uterine leiomyoma is associated with low intraoperative morbidity and short hospitalization. Limited data about the long-term outcome of ...
Novel multielement Au/La-SrTiO3 microspheres were synthesized by a solvothermal method using monodisperse gold and La-SrTiO3 nanocrystals as building blocks. The porous Au/La-SrTiO3 microspheres had a...
Broad ligament fibroids are rare and often pose clinical diagnostic difficulties. We report a case of broad ligament fibroid in a woman after hysterectomy. The lady presented to us with continuous low...
The purpose of this study was to develop novel lidocaine microspheres. Microspheres were prepared by the oil-in-water (o/w) emulsion technique using poly(d,l-lactide-co-glycolide acid) (PLGA) for the ...
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.