- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00628901
A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
A Prospective, Randomized, Single-Center Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104-3246
- Hospital of the University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Arm 2
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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.
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
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Experimental: Arm 1
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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.
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)
Time Frame: 24-hours post study procedure
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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).
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24-hours post study procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS) Maximum Level of Nausea
Time Frame: 24 hours after study procedure
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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.
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24 hours after study procedure
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Visual Analog Scale (VAS) Maximum Level of Pain
Time Frame: 24 hours after study procedure
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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.
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24 hours after study procedure
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Fluoroscopy Time
Time Frame: During the study procedure (measured in minutes)
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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.
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During the study procedure (measured in minutes)
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Procedure Time
Time Frame: During the study procedure (measured in minutes)
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Procedure time is the time in minutes of the first arterial puncture to time of hemostasis (stopping bleeding)
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During the study procedure (measured in minutes)
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Any Adverse Events That the Participant Experienced
Time Frame: During the hospitalization stay post UFE
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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.
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During the hospitalization stay post UFE
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Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score
Time Frame: Baseline
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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
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Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score
Time Frame: 3-months
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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
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Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score
Time Frame: 12 months
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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
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Health Related Quality of Life (HRQL)Subscores
Time Frame: Baseline
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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
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Health Related Quality of Life Subscores
Time Frame: 3 months
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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
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Health Related Quality of Life Subscores
Time Frame: 12 months
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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
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pamela Grady, Ph.D, Boston Scientific Corporation
- Principal Investigator: Richard Shalansky-Goldberg, MD, University of Pennsylvania
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Uterine Diseases
- Hemorrhage
- Connective Tissue Diseases
- Neoplasms, Connective Tissue
- Menstruation Disturbances
- Neoplasms, Muscle Tissue
- Uterine Hemorrhage
- Leiomyoma
- Myofibroma
- Uterine Neoplasms
- Menorrhagia
- Leiomyomatosis
Other Study ID Numbers
- M9011
- ONC-PM-022005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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