Back to resultsA Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
Primary Purpose
Leiomyoma, Uterine Fibroids, Uterine Neoplasms
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Uterine Fibroid Embolization (UFE)
Contour SE™ Microspheres
Embosphere® Microspheres
Sponsored by
About this trial
This is an interventional treatment trial for Leiomyoma focused on measuring Leiomyoma, Uterine Fibroids, Uterine Fibroid Embolization (UFE), Uterine Artery Embolization (UAE), Uterine Neoplasms, Menorrhagia
Eligibility 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
Sites / Locations
- Hospital of the University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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.
Procedure Time
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
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
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
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
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
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
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
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.
Full Information
NCT ID
NCT00628901
First Posted
February 25, 2008
Last Updated
July 2, 2012
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00628901
Brief Title
A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyoma, Uterine Fibroids, Uterine Neoplasms, Menorrhagia, Leiomyomatosis
Keywords
Leiomyoma, Uterine Fibroids, Uterine Fibroid Embolization (UFE), Uterine Artery Embolization (UAE), Uterine Neoplasms, Menorrhagia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Uterine Fibroid Embolization (UFE)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Contour SE™ Microspheres
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Embosphere® Microspheres
Intervention Description
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Primary Outcome Measure Information:
Title
Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)
Description
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).
Time Frame
24-hours post study procedure
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Maximum Level of Nausea
Description
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.
Time Frame
24 hours after study procedure
Title
Visual Analog Scale (VAS) Maximum Level of Pain
Description
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.
Time Frame
24 hours after study procedure
Title
Fluoroscopy Time
Description
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.
Time Frame
During the study procedure (measured in minutes)
Title
Procedure Time
Description
Procedure time is the time in minutes of the first arterial puncture to time of hemostasis (stopping bleeding)
Time Frame
During the study procedure (measured in minutes)
Title
Any Adverse Events That the Participant Experienced
Description
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.
Time Frame
During the hospitalization stay post UFE
Title
Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score
Description
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)
Time Frame
Baseline
Title
Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score
Description
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)
Time Frame
3-months
Title
Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score
Description
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).
Time Frame
12 months
Title
Health Related Quality of Life (HRQL)Subscores
Description
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.
Time Frame
Baseline
Title
Health Related Quality of Life Subscores
Description
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.
Time Frame
3 months
Title
Health Related Quality of Life Subscores
Description
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.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Shalansky-Goldberg, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pamela Grady, Ph.D
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-3246
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24788209
Citation
Shlansky-Goldberg RD, Rosen MA, Mondschein JI, Stavropoulos SW, Trerotola SO, Diaz-Cartelle J. Comparison of polyvinyl alcohol microspheres and tris-acryl gelatin microspheres for uterine fibroid embolization: results of a single-center randomized study. J Vasc Interv Radiol. 2014 Jun;25(6):823-32. doi: 10.1016/j.jvir.2014.03.009. Epub 2014 Apr 29.
Results Reference
derived
Learn more about this trial
A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
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