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

Phase 4

Completed

Conditions: Uterine Fibroids
Uterine Neoplasms
Menorrhagia
Leiomyoma
Leiomyomatosis

Interventions: Procedure: Uterine Fibroid Embolization (UFE)
Device: Contour SE™ Microspheres
Device: Embosphere® Microspheres

Registration Number: NCT00628901

Lead Sponsor: Boston Scientific Corporation

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 60

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Uterine Fibroid Embolization (UFE)	-
Arm 1	Contour SE™ Microspheres	-
Arm 1	Uterine Fibroid Embolization (UFE)	-
Arm 2	Embosphere® Microspheres	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)	24-hours post study procedure	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).

Secondary Outcome Measures

Name	Time	Method
Health Related Quality of Life (HRQL)Subscores	Baseline	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.
Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score	12 months	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).
Visual Analog Scale (VAS) Maximum Level of Pain	24 hours after study procedure	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.
Procedure Time	During the study procedure (measured in minutes)	Procedure time is the time in minutes of the first arterial puncture to time of hemostasis (stopping bleeding)
Fluoroscopy Time	During the study procedure (measured in minutes)	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.
Visual Analog Scale (VAS) Maximum Level of Nausea	24 hours after study procedure	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.
Any Adverse Events That the Participant Experienced	During the hospitalization stay post UFE	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.
Health Related Quality of Life Subscores	12 months	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.

Trial Locations

Locations (1): Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States