A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
- 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)
- 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.
- Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score [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 [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 [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 [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.
- Health Related Quality of Life Subscores [3 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.
- 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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M9011
- ONC-PM-022005
Study Results
Participant Flow
| Recruitment Details | Participants undergoing Uterine Fibroid Embolization for symptomatic uterine fibroids at the participating site, that met the study inclusion criteria, were approached for consent for inclusion into the study. Enrollment occurred from February 2006 to December 2009. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Contour SE Microspheres | Embosphere Microspheres |
|---|---|---|
| Arm/Group 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 | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. |
| Period Title: Overall Study | ||
| STARTED | 30 | 30 |
| COMPLETED | 27 | 29 |
| NOT COMPLETED | 3 | 1 |
Baseline Characteristics
| Arm/Group Title | Contour SE Microspheres | Embosphere Microspheres | Total |
|---|---|---|---|
| Arm/Group 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 | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. | Total of all reporting groups |
| Overall Participants | 30 | 30 | 60 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
30
100%
|
30
100%
|
60
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
43.9
(5)
|
41.7
(5.4)
|
42.8
(5.3)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
30
100%
|
30
100%
|
60
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
1
3.3%
|
1
1.7%
|
| Not Hispanic or Latino |
21
70%
|
18
60%
|
39
65%
|
| Unknown or Not Reported |
9
30%
|
11
36.7%
|
20
33.3%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
2
6.7%
|
0
0%
|
2
3.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
21
70%
|
20
66.7%
|
41
68.3%
|
| White |
7
23.3%
|
6
20%
|
13
21.7%
|
| More than one race |
0
0%
|
2
6.7%
|
2
3.3%
|
| Unknown or Not Reported |
0
0%
|
2
6.7%
|
2
3.3%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
30
100%
|
30
100%
|
60
100%
|
| Previous or concurrent gynecological disease(s) (partcipants) [Number] | |||
| # of participants with concurrent gyneco disease |
5
|
7
|
12
|
| # of participants without concurrent gyneco diseas |
25
|
23
|
48
|
| Fibroid Related Symptoms (particpants) [Number] | |||
| Abnormal Bleeding |
28
|
27
|
55
|
| Bulk/pressure |
20
|
25
|
45
|
| Pelvic Pain |
22
|
23
|
45
|
| Other |
8
|
10
|
18
|
| Number of fibroids present greater than 2cm (particpants) [Number] | |||
| 0 fibroids |
1
|
0
|
1
|
| 1 fibroid |
1
|
3
|
4
|
| 2 fibroids |
2
|
5
|
7
|
| 3 fibroids |
10
|
4
|
14
|
| 4 fibroids |
2
|
2
|
4
|
| 5 fibroids |
2
|
2
|
4
|
| 6 fibroids |
3
|
2
|
5
|
| 7-10 fibroids |
6
|
5
|
11
|
| >10 fibroids |
3
|
7
|
10
|
| Number of fibroids present less than 2 cm (participants) [Number] | |||
| 0 fibroids |
3
10%
|
3
10%
|
6
10%
|
| 1 fibroid |
2
6.7%
|
3
10%
|
5
8.3%
|
| 2 fibroids |
2
6.7%
|
1
3.3%
|
3
5%
|
| 3 fibroids |
3
10%
|
1
3.3%
|
4
6.7%
|
| 4 fibroids |
4
13.3%
|
2
6.7%
|
6
10%
|
| 5 fibroids |
2
6.7%
|
4
13.3%
|
6
10%
|
| 6 fibroids |
3
10%
|
3
10%
|
6
10%
|
| 7-10 fibroids |
4
13.3%
|
4
13.3%
|
8
13.3%
|
| >10 fibroids |
7
23.3%
|
9
30%
|
16
26.7%
|
| Type of fibroid present (participants) [Number] | |||
| Submucosal |
16
53.3%
|
20
66.7%
|
36
60%
|
| Subserosal |
26
86.7%
|
24
80%
|
50
83.3%
|
| Intramural |
28
93.3%
|
28
93.3%
|
56
93.3%
|
| Transmural |
14
46.7%
|
17
56.7%
|
31
51.7%
|
| Other, specify |
0
0%
|
0
0%
|
0
0%
|
| Cannot determine |
0
0%
|
0
0%
|
0
0%
|
| Dominant fibroid volume (cm^3) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [cm^3] |
203.3
(275.1)
|
141.1
(179.6)
|
172.2
(232.5)
|
| Uterine Volume (cm^3) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [cm^3] |
1536.7
(937.3)
|
1491.6
(1456.5)
|
1514.2
(1214.5)
|
| Maximal thickness of junctional zone (mm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mm] |
11.4
(6.6)
|
10.9
(7.9)
|
11.2
(7.2)
|
| Maximal thickness of the endometrium (mm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mm] |
7.3
(2.8)
|
8.9
(3.3)
|
8.1
(3.2)
|
| Minimal thickness of the myometrium (mm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mm] |
11.2
(5.1)
|
9.5
(4.2)
|
10.3
(4.7)
|
| Concomitant adenomyosis (participants) [Number] | |||
| Focal |
7
23.3%
|
5
16.7%
|
12
20%
|
| Diffuse |
2
6.7%
|
2
6.7%
|
4
6.7%
|
| Cannot Determine |
0
0%
|
0
0%
|
0
0%
|
| Presence of endometrial scar (participants) [Number] | |||
| Yes |
0
0%
|
0
0%
|
0
0%
|
| No |
30
100%
|
30
100%
|
60
100%
|
| Presence of myometrial scar (participants) [Number] | |||
| Yes |
7
23.3%
|
7
23.3%
|
14
23.3%
|
| No |
23
76.7%
|
23
76.7%
|
46
76.7%
|
| Assessment of myometrial perfusion (participants) [Number] | |||
| Normal |
30
100%
|
28
93.3%
|
58
96.7%
|
| Mildly Decreased |
0
0%
|
1
3.3%
|
1
1.7%
|
| Moderately Decreased |
0
0%
|
0
0%
|
0
0%
|
| Severly Decreased/Infarcted |
0
0%
|
0
0%
|
0
0%
|
| Ovaries seen (participants) [Number] | |||
| Yes |
29
96.7%
|
29
96.7%
|
58
96.7%
|
| No |
1
3.3%
|
1
3.3%
|
2
3.3%
|
| Adnexal Pathology (participants) [Number] | |||
| Endometrioma/Endometriosis |
0
0%
|
1
3.3%
|
1
1.7%
|
| Cyst |
3
10%
|
2
6.7%
|
5
8.3%
|
| Other |
2
6.7%
|
0
0%
|
2
3.3%
|
| Obvious contribution to the uterine blood supply from the ovarian artery (participants) [Number] | |||
| Yes |
0
0%
|
1
3.3%
|
1
1.7%
|
| No |
30
100%
|
29
96.7%
|
59
98.3%
|
| Maximal Thickness of the myometrium (mm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mm] |
26.8
(8.1)
|
25.0
(7.4)
|
25.9
(7.8)
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Contour SE Microspheres | Embosphere Microspheres |
|---|---|---|
| Arm/Group 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 | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. |
| Measure Participants | 29 | 30 |
| Number [participants] |
29
96.7%
|
29
96.7%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Contour SE Microspheres | Embosphere Microspheres |
|---|---|---|
| Arm/Group 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 | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. |
| Measure Participants | 30 | 30 |
| Mean (Standard Deviation) [cm] |
5.5
(3)
|
4.8
(3.2)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Contour SE Microspheres | Embosphere Microspheres |
|---|---|---|
| Arm/Group 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 | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. |
| Measure Participants | 30 | 30 |
| Mean (Standard Deviation) [cm] |
6.0
(2.9)
|
5.6
(2.8)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Contour SE Microspheres | Embosphere Microspheres |
|---|---|---|
| Arm/Group 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 | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. |
| Measure Participants | 30 | 30 |
| Mean (Standard Deviation) [minutes] |
31.1
(19.4)
|
24.9
(8.7)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Contour SE Microspheres | Embosphere Microspheres |
|---|---|---|
| Arm/Group 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 | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. |
| Measure Participants | 30 | 30 |
| Mean (Standard Deviation) [minutes] |
102
(49.9)
|
95.6
(39.6)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Contour SE Microspheres | Embosphere Microspheres |
|---|---|---|
| Arm/Group 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 | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. |
| Measure Participants | 30 | 30 |
| Number [events] |
68
|
58
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Contour SE Microspheres | Embosphere Microspheres |
|---|---|---|
| Arm/Group 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 | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. |
| Measure Participants | 30 | 30 |
| Mean (Standard Deviation) [Scores on a scale] |
64.2
(20.6)
|
65.1
(20.3)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Contour SE Microspheres | Embosphere Microspheres |
|---|---|---|
| Arm/Group 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 | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. |
| Measure Participants | 28 | 28 |
| Mean (Standard Deviation) [Scores on a scale] |
16.3
(12.1)
|
22.7
(20.5)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Contour SE Microspheres | Embosphere Microspheres |
|---|---|---|
| Arm/Group 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 | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. |
| Measure Participants | 26 | 28 |
| Mean (Standard Deviation) [Scores on a scale] |
18.0
(15.5)
|
22.9
(17.8)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Contour SE Microspheres | Embosphere Microspheres |
|---|---|---|
| Arm/Group 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 | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. |
| Measure Participants | 29 | 29 |
| Mean (Standard Deviation) [Scores on a scale] |
42.1
(20.2)
|
42.0
(23.7)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Contour SE Microspheres | Embosphere Microspheres |
|---|---|---|
| Arm/Group 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 | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. |
| Measure Participants | 28 | 28 |
| Mean (Standard Deviation) [Scores] |
90.0
(13.1)
|
90.0
(11.7)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Contour SE Microspheres | Embosphere Microspheres |
|---|---|---|
| Arm/Group 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 | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. |
| Measure Participants | 25 | 28 |
| Mean (Standard Deviation) [Scores on a scale] |
89.8
(14.5)
|
89.9
(11.5)
|
Adverse Events
| Time Frame | Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Contour SE Microspheres | Embosphere Microspheres | ||
| Arm/Group 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 | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. | ||
All Cause Mortality |
||||
| Contour SE Microspheres | Embosphere Microspheres | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Contour SE Microspheres | Embosphere Microspheres | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/30 (3.3%) | 3/30 (10%) | ||
| Gastrointestinal disorders | ||||
| Mallory-Weiss syndrome | 0/30 (0%) | 0 | 1/30 (3.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Lumbar Spinal Stenosis | 0/30 (0%) | 0 | 1/30 (3.3%) | 1 |
| Reproductive system and breast disorders | ||||
| Endometriosis | 1/30 (3.3%) | 1 | 1/30 (3.3%) | 1 |
| Ovarian cyst | 1/30 (3.3%) | 1 | 0/30 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Contour SE Microspheres | Embosphere Microspheres | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 25/30 (83.3%) | 22/30 (73.3%) | ||
| Gastrointestinal disorders | ||||
| Abdominal Pain | 2/30 (6.7%) | 2 | 2/30 (6.7%) | 2 |
| Constipation | 3/30 (10%) | 3 | 4/30 (13.3%) | 5 |
| Flatulence | 0/30 (0%) | 0 | 2/30 (6.7%) | 2 |
| Nausea | 2/30 (6.7%) | 2 | 1/30 (3.3%) | 1 |
| Vomiting | 13/30 (43.3%) | 14 | 11/30 (36.7%) | 12 |
| General disorders | ||||
| Fatigue | 3/30 (10%) | 3 | 0/30 (0%) | 0 |
| Pyrexia | 0/30 (0%) | 0 | 2/30 (6.7%) | 2 |
| Immune system disorders | ||||
| Hypersensitivity | 0/30 (0%) | 0 | 2/30 (6.7%) | 2 |
| Infections and infestations | ||||
| Infection | 0/30 (0%) | 0 | 2/30 (6.7%) | 2 |
| Injury, poisoning and procedural complications | ||||
| Procedural vomiting | 4/30 (13.3%) | 4 | 1/30 (3.3%) | 1 |
| Vascular Injury | 0/30 (0%) | 0 | 3/30 (10%) | 3 |
| Musculoskeletal and connective tissue disorders | ||||
| Back Pain | 0/30 (0%) | 0 | 2/30 (6.7%) | 2 |
| Nervous system disorders | ||||
| Sciatica | 2/30 (6.7%) | 2 | 0/30 (0%) | 0 |
| Renal and urinary disorders | ||||
| Incontinence | 2/30 (6.7%) | 2 | 0/30 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Menorrhagia | 2/30 (6.7%) | 2 | 3/30 (10%) | 3 |
| Pelvic Pain | 4/30 (13.3%) | 4 | 1/30 (3.3%) | 1 |
| Vaginal Exfoliation | 2/30 (6.7%) | 2 | 4/30 (13.3%) | 4 |
| Vaginal discharge | 2/30 (6.7%) | 2 | 1/30 (3.3%) | 1 |
| Vascular disorders | ||||
| Haematoma | 3/30 (10%) | 3 | 4/30 (13.3%) | 4 |
| Hypertension | 5/30 (16.7%) | 5 | 6/30 (20%) | 7 |
| Vasospasm | 3/30 (10%) | 3 | 2/30 (6.7%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication to remove any confidential information or other proprietary information of Sponsor.
Results Point of Contact
| Name/Title | Ana Becker / Sr. Clinical Program Manager |
|---|---|
| Organization | Boston Scientific |
| Phone | 651-581-4605 |
| Ana.Becker@bsci.com |
- M9011
- ONC-PM-022005