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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Randomized, Single-Center Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)

Conditions
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Leiomyoma, Uterine Fibroids, Uterine Neoplasms, Menorrhagia, Leiomyomatosis

Intervention / Treatment
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* Procedure: Uterine Fibroid Embolization (UFE)
* Device: Contour SE™ Microspheres
* Device: Embosphere® Microspheres


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: One or more of the following symptoms: abnormal menstrual bleeding, infertility related to fibroids, pelvic pain, and/or bulk/pressure related symptoms attributed to fibroids: i.e., pelvic pressure, abdominal enlargement, abdominal bloating, gastrointestinal pressure symptoms (backache, constipation), dysfunction of the urinary bladder (urinary frequency, urinary retention), vaginal pressure, and rectal pressure. Severity of the symptom(s) warrants invasive treatment Willing and able to complete the follow-up requirements outlined in the study design section of the protocol Willing to sign a consent form Exclusion Criteria: Active pelvic inflammatory disease or infection Any malignancy of the pelvic region Endometrial neoplasia or hyperplasia Presence of one or more submucosal fibroid(s) with more than 50% growth into the uterine cavity Presence of pedunculated serosal fibroid as the dominant fibroid(s) Fibroids with significant collateral feeding by vessels other than the uterine arteries Presence of arteries supplying the fibroid are not large enough to accept 700-900 micron or 900-1200 micron microspheres Coagulopathy Atypical anatomy that will not allow for bilateral UFE Subject with known severe contrast allergy Subjects with known moderate to severe renal disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Procedure: Uterine Fibroid Embolization (UFE)<br>* Uterine Fibroid Embolization is used in treating Uterine Fibroids. The procedure involves injecting embolization particles into the fibroid via the uterine artery which causes the fibroid to shrink or subside. Patients are usually released from the hospital the day after the procedure.<br>Device: Contour SE™ Microspheres<br>* Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations<br>|
| Active Comparator: Arm 2<br> | Procedure: Uterine Fibroid Embolization (UFE)<br>* Uterine Fibroid Embolization is used in treating Uterine Fibroids. The procedure involves injecting embolization particles into the fibroid via the uterine artery which causes the fibroid to shrink or subside. Patients are usually released from the hospital the day after the procedure.<br>Device: Embosphere® Microspheres<br>* Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI) | MRI uses a large circular magnet and radio waves to generate signals from atoms in the body. These signals are used to construct images of internal structures. Injection of contrast through an IV is done during the test to enhance the view of the uterus. Contrast enhanced MRI was used as a test in this study to verify if blood supply to the fibroids was blocked or interrupted (devascularization). | 24-hours post study procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Maximum Level of Nausea | Maximum level of nausea was measured using the Visual Analog Scale(VAS). The patient is presented with a picture of a straight line that is 0-10 cm long. The left side of the line (0 cm) represents 'no nausea' and the right side (10cm) of the line represents 'worst nausea imaginable'. The patient is asked to place a mark on the line that represents their level of nausea. For example, a reading of 10cm = worst nausea imaginable. | 24 hours after study procedure | 
| Visual Analog Scale (VAS) Maximum Level of Pain | Maximum level of pain was measured using the Visual Analog Scale(VAS). The patient is presented with a picture of a straight line that is 0-10 cm long. The left side of the line (0 cm) represents 'no pain' and the right side (10cm) of the line represents 'worst imaginable'. The patient is asked to place a mark on the line that represents their level of pain. For example, a reading of 10cm = worst imaginable pain. | 24 hours after study procedure | 
| Fluoroscopy Time | Fluoroscopy is the method that provides real-time X ray imaging used for guiding a variety of diagnostic and interventional procedures. Fluoroscopy time is described as the amount of time the patient underwent fluoroscopy. | During the study procedure (measured in minutes) | 
| Procedure Time | Procedure time is the time in minutes of the first arterial puncture to time of hemostasis (stopping bleeding) | During the study procedure (measured in minutes) | 
| Any Adverse Events That the Participant Experienced | Summary of investigator reported adverse events and adverse device effects, including all serious adverse events and unanticipated adverse device effects. Adverse events were collected systematically, meaning they were collected during the participant's follow-up visit, during telephone contacts, or during medical record review. | During the hospitalization stay post UFE | 
| Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score | The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months. The scores are added and the final total scores range from 0-100. The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad) | Baseline | 
| Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score | The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months. The scores are added and the final total scores range from 0-100. The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad) | 3-months | 
| Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score | The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months. The scores are added and the final total scores range from 0-100.The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad). | 12 months | 
| Health Related Quality of Life (HRQL)Subscores | The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL. Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores. | Baseline | 
| Health Related Quality of Life Subscores | The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL. Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores. | 3 months | 
| Health Related Quality of Life Subscores | The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL. Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leiomyoma, Uterine Fibroids, Uterine Fibroid Embolization (UFE), Uterine Artery Embolization (UAE), Uterine Neoplasms, Menorrhagia