Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Quality of Life

Femoral arterial puncture for the uterine fibroid embolization procedure

Radial arterial puncture for the uterine fibroid embolization procedure

Arterial access

John Kachura

Randomized trial comparing uterine fibroid embolization patient satisfaction and quality of life with femoral versus radial arterial access

1:1 randomized trial comparing patient satisfaction and quality of life with femoral versus radial arterial access for uterine fibroid embolization

Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial

Based on visual analog scale (min 0, max 10; higher score indicates better outcome)

Complications categorized based on the Society of Interventional Radiology Standards of Practice Guideline

Fluoroscopy time used during the procedure

Cost of disposable equipment used for the procedure

Health related quality of life short form-8 questionnaire (raw score converted to standardised score min 0, max 100; higher score indicates better outcome)

Mount Sinai Hospital, Canada

Interventional Radiologist; Associate Professor of Medical Imaging

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Neoplasms

Leiomyomatosis

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Uterine fibroid embolization BeadBlock™

Uterine fibroid embolization Embosphere®

Robert Worthington-Kirsch, MD

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.

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

1. 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

1. 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.
2. 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.

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

Feasibility Evaluation of the Embolic Agent BeadBlock™ in the Treatment of Uterine Fibroids With Uterine Artery Embolization With Comparison of Study Endpoints to Embosphere®

Terumo Medical Corporation

Biocompatibles UK Ltd

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

Robert Worthington-Kirsch MD

Hysterectomy

Myomectomy

Uterine Fibroid Embolization

James B Spies, MD

LTC G. Larry Maxwell, MD

Richard Guido, MD

Linda D Bradley, MD

The purpose of this study is to determine the change in symptoms and health-related quality of life in patients undergoing treatment for fibroids. Results from the questionnaire will be compared with results obtained from patients who do not have fibroids in order to determine a score range that differentiates these two groups.

Uterine fibroids are the most common benign uterine tumor affecting approximately 70% of all women in the United States. Sixty percent of the 600,000 hysterectomies performed in the United States annually are done because of uterine fibroids. Hysterectomy has been the definitive treatment for fibroids and has been demonstrated to be effective in controlling symptoms. However, there have been few studies comparing the outcome of hysterectomy to other surgical and non-surgical therapies or to the outcomes experienced by a "normal" population, i.e. those not diagnosed with fibroids. Similarly, the relative effectiveness of myomectomy and uterine fibroid embolization has not been evaluated in the context of other fibroid therapies and minimally invasive variations. Fibroid symptoms experienced by patients are subjective and have not been shown to correlate with fibroid number, size, location, or any other clinical measure of fibroids. As symptoms and their impact are the primary outcomes experienced by patients, a validated questionnaire to measure this impact is needed.

The Uterine Fibroid Symptom and Quality of Life Questionnaire (UFS-QoL) was developed from focus groups of women with leiomyomata. The original items captured key symptoms and areas of life impact voiced by the focus group participants. Content validity was established through cognitive debriefings of women with leiomyomata and review by expert clinicians. The UFS-QoL was then validated in a patient population of women with leiomyomata as well as "normal" controls.

Using the UFS-Qol as the primary measure, this study will provide the basis of comparison for women with uterine fibroids both before and after therapy. "Normal" scores will be established from patients without fibroids. These data will provide the basis for comparing these outcomes to those resulting from a variety of investigational therapies. It will also provide insight into the progression of fibroid-related symptoms in patients established as normal at baseline.

The objectives of this study are:

A. To determine the change in symptoms and health-related quality of life in patients undergoing hysterectomy, myomectomy, and uterine fibroid embolization.

B. To compare the outcomes of each intervention with a normal control group as well as with the other therapies.

C. To validate the UFS-QoL questionnaire in a normal population to determine a normal score range.

D. To validate the UFS-QoL questionnaire in hysterectomy patients to determine a "normal" score for patients without a uterus.

Questionnaire Study to Assess Quality of Life After Treatment of Fibroids

Outcome From Fibroid Therapies: A Comparison With Normal Controls

Walter Reed Army Medical Center

Georgetown University

The Cleveland Clinic

University of Pittsburgh

U.S. Army Medical Research and Development Command

Patients will undergo the uterine fibroid embolization procedure with Embozene Microspheres as the embolic agent.

Patients will undergo the uterine fibroid embolization procedure with Embosphere Microspheres as the embolic agent.

This procedure involves the administration of the study device into the uterine arteries to block the flow of blood in these vessels. This deprives fibroid tumors within the uterus of their blood flow, which can cause the tumors to die. This in turn can lead to the relief of symptoms associated with fibroids.

Barbara MacDowell

Gary Siskin, MD

The purpose of this study is to evaluate the safety and effectiveness of Embozene Microspheres compared with Embosphere Microspheres for the treatment of symptomatic uterine fibroids. A total of 118 patents with symptomatic uterine fibroids will be enrolled at 6 sites. Symptom severity, health-related quality of life, and the appearance of the fibroids will be assessed prior to treatment. Patients will then undergo the uterine fibroid embolization procedure with either Embosphere Microspheres or Embozene Microspheres, which will be randomly assigned. Clinical outcomes will be assessed 1 month, 3 months, 6 months and 12 months after the procedure, and imaging outcomes will be obtained 3 months after the procedure.

The uterine fibroid embolization (UFE) procedure is an accepted, minimally invasive treatment option for patients with symptomatic uterine fibroids. Studies evaluating the outcomes after this procedure have established that the use of polyvinyl alcohol particles and Embosphere Microspheres is associated with best clinical and imaging outcomes. Embozene Microspheres represent a new embolic agent that is being evaluated for use for the treatment of symptomatic fibroids. The purpose of this study is to evaluate the safety and effectiveness of Embozene Microspheres compared with Embosphere Microspheres for the treatment of symptomatic uterine fibroids.

A total of 118 patents with symptomatic uterine fibroids will be enrolled at 6 sites. A questionnaire designed to assess symptom severity and health-related quality of life in patients will be administered to patients at the time of enrollment. In addition, a contrast-enhanced magnetic resonance imaging (MRI) examination will be performed to confirm the diagnosis of fibroids. Patients will then undergo the uterine fibroid embolization procedure. The embolic agent used for the procedure (Embosphere Microspheres or Embozene Microspheres) will be randomly assigned. Patients will be seen 1 month, 3 months, and 6 months and contacted 12 months after the procedure so that the same questionnaire can be used to assess clinical outcomes. In addition, an MRI will be performed 3 months after the procedure to determine the imaging response to treatment.

Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization

Safety and Efficacy of Embozene® Microspheres for Uterine Fibroid Embolization Compared to Embosphere® Microspheres for Symptomatic Relief From Uterine Fibroids

The primary effectiveness endpoint for this study is the proportion of patients with a global rate of infarction for all fibroids present within the uterus that is \>90% as seen on contrast-enhanced MRI.

The percentage of patients experiencing improvement in symptom severity after the uterine fibroid embolization procedure.

The percentage of patients experiencing improvement in health-related quality of life after the uterine fibroid embolization procedure.

The change in uterine volume as seen on MRI examinations performed 3 months after the embolization procedure.

The change in dominant fibroid volume as seen on MRI examinations performed 3 months after the embolization procedure.

The frequency of adverse events occurring after embolization will be monitored and reported.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial	NCT03021720	Uterine Fibroid	Arterial access	18 Years -	Mount Sinai Hospital, Canada
Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlock™ Embolic Agent	NCT00361036	Leiomyoma Leiomyomatosis Uterine Neoplas...	Uterine fibroid... Uterine fibroid...	30 Years - 50 Years	Worthington-Kirsch, Robert L., M.D.
Questionnaire Study to Assess Quality of Life After Treatment of Fibroids	NCT00390494	Leiomyoma	Hysterectomy Myomectomy Uterine Fibroid...	35 Years - 50 Years	Walter Reed Army Medical Center
Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlock™ Embolic Agent	NCT00361036	Leiomyoma Leiomyomatosis Uterine Neoplas...	Uterine fibroid... Uterine fibroid...	30 Years - 50 Years	Worthington-Kirsch, Robert L., M.D.
Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization	NCT02884960	Uterine Fibroid...	Uterine Fibroid...	30 Years - 50 Years	Community Care Physicians, P.C.

Spots Global Cancer Trial Database for uterine fibroid embolization