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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Boston Scientific Corporation

Current Primary Outcome: Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI) [ Time Frame: 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).


Original Primary Outcome: Fibroid devascularization measured by contrast enhanced MRI [ Time Frame: 24-hours post UFE ]

Current Secondary Outcome:

  • Visual Analog Scale (VAS) Maximum Level of Nausea [ Time Frame: 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.
  • Visual Analog Scale (VAS) Maximum Level of Pain [ Time Frame: 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.
  • Fluoroscopy Time [ Time Frame: 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.
  • Procedure Time [ Time Frame: 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)
  • Any Adverse Events That the Participant Experienced [ Time Frame: 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.
  • Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score [ Time Frame: Baseline ]

    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)

  • Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score [ Time Frame: 3-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)

  • Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score [ Time Frame: 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).

  • Health Related Quality of Life (HRQL)Subscores [ Time Frame: 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 (H

    Original Secondary Outcome:

    • Maximum level of nausea and pain [ Time Frame: During the hospitalization stay post UFE ]
    • Fluoroscopy Time [ Time Frame: During the hospitalization stay post UFE ]
    • Procedure Time [ Time Frame: During the hospitalization stay post UFE ]
    • Any adverse events that the subject experienced [ Time Frame: During the hospitalization stay post UFE, 24 hours, 3 months, and 12 months post procedure ]
    • Quality of life questionaire [ Time Frame: Baseline, 3 and 12 Months ]


    Information By: Boston Scientific Corporation

    Dates:
    Date Received: February 25, 2008
    Date Started: January 2006
    Date Completion:
    Last Updated: July 2, 2012
    Last Verified: July 2012