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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00628901
First received: February 25, 2008
Last updated: July 2, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Leiomyoma
Uterine Fibroids
Uterine Neoplasms
Menorrhagia
Leiomyomatosis
Procedure: Uterine Fibroid Embolization (UFE)
Device: Contour SE™ Microspheres
Device: Embosphere® Microspheres
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Single-Center Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI) [ Time Frame: 24-hours post study procedure ] [ Designated as safety issue: No ]
    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:
  • Visual Analog Scale (VAS) Maximum Level of Nausea [ Time Frame: 24 hours after study procedure ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]

    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.


  • Health Related Quality of Life Subscores [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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.


  • Health Related Quality of Life Subscores [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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.



Enrollment: 60
Study Start Date: January 2006
Study Completion Date: January 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Procedure: Uterine Fibroid Embolization (UFE)
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.
Device: Contour SE™ Microspheres
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
Active Comparator: Arm 2 Procedure: Uterine Fibroid Embolization (UFE)
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.
Device: Embosphere® Microspheres
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628901

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-3246
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Richard Shalansky-Goldberg, MD University of Pennsylvania
Study Director: Pamela Grady, Ph.D Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00628901     History of Changes
Other Study ID Numbers: M9011, ONC-PM-022005
Study First Received: February 25, 2008
Results First Received: June 13, 2011
Last Updated: July 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:
Leiomyoma
Uterine Fibroids
Uterine Fibroid Embolization (UFE)
Uterine Artery Embolization (UAE)
Uterine Neoplasms
Menorrhagia

Additional relevant MeSH terms:
Leiomyoma
Leiomyomatosis
Menorrhagia
Myofibroma
Neoplasms
Uterine Neoplasms
Connective Tissue Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Menstruation Disturbances
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Pathologic Processes
Urogenital Neoplasms
Uterine Diseases
Uterine Hemorrhage

ClinicalTrials.gov processed this record on November 24, 2014