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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
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 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...
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...
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 ...
A uterine prolapse associated with a leiomyoma (fibroid) was observed in a live-stranded Atlantic spotted dolphin (Stenella frontalis). A 7Â cm segment of the reproductive tract including the cervix, ...
To assess patients' satisfaction and the intermediate and long-term patterns of symptom progression following uterine artery fibroid embolization (UAE).
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).
The etiology and pathophysiology of uterine leiomyomas, benign smooth muscle tumors of the uterus, are not well understood. To evaluate the role of mitochondria in uterine leiomyoma, we compared elect...
To evaluate the clinical feasibility and diagnostic accuracy of three-dimensional (3D) quantitative magnetic resonance (MR) imaging for the assessment of total lesion volume (TLV) and enhancing lesion...
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.