Trial Outcomes & Findings for A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE) (NCT NCT00628901)

Last Updated: 2012-07-11

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

24-hours post study procedure

Results posted on

2012-07-11

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	Embosphere Microspheres Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Overall Study STARTED	30	30
Overall Study COMPLETED	27	29
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contour SE Microspheres n=30 Participants 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	Embosphere Microspheres n=30 Participants Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	43.9 years STANDARD_DEVIATION 5 • n=5 Participants	41.7 years STANDARD_DEVIATION 5.4 • n=7 Participants	42.8 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Previous or concurrent gynecological disease(s) # of participants with concurrent gyneco disease	5 partcipants n=5 Participants	7 partcipants n=7 Participants	12 partcipants n=5 Participants
Previous or concurrent gynecological disease(s) # of participants without concurrent gyneco diseas	25 partcipants n=5 Participants	23 partcipants n=7 Participants	48 partcipants n=5 Participants
Fibroid Related Symptoms Abnormal Bleeding	28 particpants n=5 Participants	27 particpants n=7 Participants	55 particpants n=5 Participants
Fibroid Related Symptoms Bulk/pressure	20 particpants n=5 Participants	25 particpants n=7 Participants	45 particpants n=5 Participants
Fibroid Related Symptoms Pelvic Pain	22 particpants n=5 Participants	23 particpants n=7 Participants	45 particpants n=5 Participants
Fibroid Related Symptoms Other	8 particpants n=5 Participants	10 particpants n=7 Participants	18 particpants n=5 Participants
Number of fibroids present greater than 2cm 0 fibroids	1 particpants n=5 Participants	0 particpants n=7 Participants	1 particpants n=5 Participants
Number of fibroids present greater than 2cm 1 fibroid	1 particpants n=5 Participants	3 particpants n=7 Participants	4 particpants n=5 Participants
Number of fibroids present greater than 2cm 2 fibroids	2 particpants n=5 Participants	5 particpants n=7 Participants	7 particpants n=5 Participants
Number of fibroids present greater than 2cm 3 fibroids	10 particpants n=5 Participants	4 particpants n=7 Participants	14 particpants n=5 Participants
Number of fibroids present greater than 2cm 4 fibroids	2 particpants n=5 Participants	2 particpants n=7 Participants	4 particpants n=5 Participants
Number of fibroids present greater than 2cm 5 fibroids	2 particpants n=5 Participants	2 particpants n=7 Participants	4 particpants n=5 Participants
Number of fibroids present greater than 2cm 6 fibroids	3 particpants n=5 Participants	2 particpants n=7 Participants	5 particpants n=5 Participants
Number of fibroids present greater than 2cm 7-10 fibroids	6 particpants n=5 Participants	5 particpants n=7 Participants	11 particpants n=5 Participants
Number of fibroids present greater than 2cm >10 fibroids	3 particpants n=5 Participants	7 particpants n=7 Participants	10 particpants n=5 Participants
Number of fibroids present less than 2 cm 0 fibroids	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Number of fibroids present less than 2 cm 1 fibroid	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Number of fibroids present less than 2 cm 2 fibroids	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Number of fibroids present less than 2 cm 3 fibroids	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Number of fibroids present less than 2 cm 4 fibroids	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Number of fibroids present less than 2 cm 5 fibroids	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Number of fibroids present less than 2 cm 6 fibroids	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Number of fibroids present less than 2 cm 7-10 fibroids	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Number of fibroids present less than 2 cm >10 fibroids	7 participants n=5 Participants	9 participants n=7 Participants	16 participants n=5 Participants
Type of fibroid present Submucosal	16 participants n=5 Participants	20 participants n=7 Participants	36 participants n=5 Participants
Type of fibroid present Subserosal	26 participants n=5 Participants	24 participants n=7 Participants	50 participants n=5 Participants
Type of fibroid present Intramural	28 participants n=5 Participants	28 participants n=7 Participants	56 participants n=5 Participants
Type of fibroid present Transmural	14 participants n=5 Participants	17 participants n=7 Participants	31 participants n=5 Participants
Type of fibroid present Other, specify	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Type of fibroid present Cannot determine	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Dominant fibroid volume	203.3 cm^3 STANDARD_DEVIATION 275.1 • n=5 Participants	141.1 cm^3 STANDARD_DEVIATION 179.6 • n=7 Participants	172.2 cm^3 STANDARD_DEVIATION 232.5 • n=5 Participants
Uterine Volume	1536.7 cm^3 STANDARD_DEVIATION 937.3 • n=5 Participants	1491.6 cm^3 STANDARD_DEVIATION 1456.5 • n=7 Participants	1514.2 cm^3 STANDARD_DEVIATION 1214.5 • n=5 Participants
Maximal thickness of junctional zone	11.4 mm STANDARD_DEVIATION 6.6 • n=5 Participants	10.9 mm STANDARD_DEVIATION 7.9 • n=7 Participants	11.2 mm STANDARD_DEVIATION 7.2 • n=5 Participants
Maximal thickness of the endometrium	7.3 mm STANDARD_DEVIATION 2.8 • n=5 Participants	8.9 mm STANDARD_DEVIATION 3.3 • n=7 Participants	8.1 mm STANDARD_DEVIATION 3.2 • n=5 Participants
Minimal thickness of the myometrium	11.2 mm STANDARD_DEVIATION 5.1 • n=5 Participants	9.5 mm STANDARD_DEVIATION 4.2 • n=7 Participants	10.3 mm STANDARD_DEVIATION 4.7 • n=5 Participants
Concomitant adenomyosis Focal	7 participants n=5 Participants	5 participants n=7 Participants	12 participants n=5 Participants
Concomitant adenomyosis Diffuse	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Concomitant adenomyosis Cannot Determine	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Presence of endometrial scar Yes	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Presence of endometrial scar No	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Presence of myometrial scar Yes	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Presence of myometrial scar No	23 participants n=5 Participants	23 participants n=7 Participants	46 participants n=5 Participants
Assessment of myometrial perfusion Normal	30 participants n=5 Participants	28 participants n=7 Participants	58 participants n=5 Participants
Assessment of myometrial perfusion Mildly Decreased	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Assessment of myometrial perfusion Moderately Decreased	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Assessment of myometrial perfusion Severly Decreased/Infarcted	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Ovaries seen Yes	29 participants n=5 Participants	29 participants n=7 Participants	58 participants n=5 Participants
Ovaries seen No	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Adnexal Pathology Endometrioma/Endometriosis	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Adnexal Pathology Cyst	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Adnexal Pathology Other	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Obvious contribution to the uterine blood supply from the ovarian artery Yes	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Obvious contribution to the uterine blood supply from the ovarian artery No	30 participants n=5 Participants	29 participants n=7 Participants	59 participants n=5 Participants
Maximal Thickness of the myometrium	26.8 mm STANDARD_DEVIATION 8.1 • n=5 Participants	25.0 mm STANDARD_DEVIATION 7.4 • n=7 Participants	25.9 mm STANDARD_DEVIATION 7.8 • n=5 Participants

PRIMARY outcome

Timeframe: 24-hours post study procedure

Outcome measures

Outcome measures
Measure	Contour SE Microspheres n=29 Participants 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	Embosphere Microspheres n=30 Participants Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)	29 participants	29 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Contour SE Microspheres n=30 Participants 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	Embosphere Microspheres n=30 Participants Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Visual Analog Scale (VAS) Maximum Level of Nausea	5.5 cm Standard Deviation 3	4.8 cm Standard Deviation 3.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Contour SE Microspheres n=30 Participants 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	Embosphere Microspheres n=30 Participants Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Visual Analog Scale (VAS) Maximum Level of Pain	6.0 cm Standard Deviation 2.9	5.6 cm Standard Deviation 2.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Contour SE Microspheres n=30 Participants 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	Embosphere Microspheres n=30 Participants Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Fluoroscopy Time	31.1 minutes Standard Deviation 19.4	24.9 minutes Standard Deviation 8.7

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Contour SE Microspheres n=30 Participants 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	Embosphere Microspheres n=30 Participants Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Procedure Time	102 minutes Standard Deviation 49.9	95.6 minutes Standard Deviation 39.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Contour SE Microspheres n=30 Participants 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	Embosphere Microspheres n=30 Participants Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Any Adverse Events That the Participant Experienced	68 events	58 events

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Contour SE Microspheres n=30 Participants 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	Embosphere Microspheres n=30 Participants Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score	64.2 Scores on a scale Standard Deviation 20.6	65.1 Scores on a scale Standard Deviation 20.3

SECONDARY outcome

Timeframe: 3-months

Outcome measures

Outcome measures
Measure	Contour SE Microspheres n=28 Participants 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	Embosphere Microspheres n=28 Participants Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score	16.3 Scores on a scale Standard Deviation 12.1	22.7 Scores on a scale Standard Deviation 20.5

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Contour SE Microspheres n=26 Participants 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	Embosphere Microspheres n=28 Participants Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score	18.0 Scores on a scale Standard Deviation 15.5	22.9 Scores on a scale Standard Deviation 17.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Contour SE Microspheres n=29 Participants 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	Embosphere Microspheres n=29 Participants Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Health Related Quality of Life (HRQL)Subscores	42.1 Scores on a scale Standard Deviation 20.2	42.0 Scores on a scale Standard Deviation 23.7

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Contour SE Microspheres n=28 Participants 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	Embosphere Microspheres n=28 Participants Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Health Related Quality of Life Subscores	90.0 Scores Standard Deviation 13.1	90.0 Scores Standard Deviation 11.7

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Contour SE Microspheres n=25 Participants 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	Embosphere Microspheres n=28 Participants Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Health Related Quality of Life Subscores	89.8 Scores on a scale Standard Deviation 14.5	89.9 Scores on a scale Standard Deviation 11.5

Adverse Events

Contour SE Microspheres

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Embosphere Microspheres

Serious events: 3 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Contour SE Microspheres n=30 participants at risk 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	Embosphere Microspheres n=30 participants at risk Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Reproductive system and breast disorders Endometriosis	3.3% 1/30 • Number of events 1 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	3.3% 1/30 • Number of events 1 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	0.00% 0/30 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	3.3% 1/30 • Number of events 1 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/30 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	3.3% 1/30 • Number of events 1 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Reproductive system and breast disorders Ovarian cyst	3.3% 1/30 • Number of events 1 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	0.00% 0/30 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.

Other adverse events

Additional Information

Ana Becker / Sr. Clinical Program Manager

Boston Scientific

Phone: 651-581-4605

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Contour SE Microspheres n=30 participants at risk 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	Embosphere Microspheres n=30 participants at risk Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
General disorders Fatigue	10.0% 3/30 • Number of events 3 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	0.00% 0/30 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Gastrointestinal disorders Flatulence	0.00% 0/30 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	6.7% 2/30 • Number of events 2 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Vascular disorders Haematoma	10.0% 3/30 • Number of events 3 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	13.3% 4/30 • Number of events 4 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Gastrointestinal disorders Abdominal Pain	6.7% 2/30 • Number of events 2 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	6.7% 2/30 • Number of events 2 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/30 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	6.7% 2/30 • Number of events 2 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Gastrointestinal disorders Constipation	10.0% 3/30 • Number of events 3 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	13.3% 4/30 • Number of events 5 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Immune system disorders Hypersensitivity	0.00% 0/30 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	6.7% 2/30 • Number of events 2 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Vascular disorders Hypertension	16.7% 5/30 • Number of events 5 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	20.0% 6/30 • Number of events 7 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Renal and urinary disorders Incontinence	6.7% 2/30 • Number of events 2 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	0.00% 0/30 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Infections and infestations Infection	0.00% 0/30 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	6.7% 2/30 • Number of events 2 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Reproductive system and breast disorders Menorrhagia	6.7% 2/30 • Number of events 2 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	10.0% 3/30 • Number of events 3 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Gastrointestinal disorders Nausea	6.7% 2/30 • Number of events 2 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	3.3% 1/30 • Number of events 1 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Reproductive system and breast disorders Pelvic Pain	13.3% 4/30 • Number of events 4 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	3.3% 1/30 • Number of events 1 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Injury, poisoning and procedural complications Procedural vomiting	13.3% 4/30 • Number of events 4 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	3.3% 1/30 • Number of events 1 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
General disorders Pyrexia	0.00% 0/30 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	6.7% 2/30 • Number of events 2 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Nervous system disorders Sciatica	6.7% 2/30 • Number of events 2 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	0.00% 0/30 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Reproductive system and breast disorders Vaginal Exfoliation	6.7% 2/30 • Number of events 2 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	13.3% 4/30 • Number of events 4 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Reproductive system and breast disorders Vaginal discharge	6.7% 2/30 • Number of events 2 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	3.3% 1/30 • Number of events 1 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Injury, poisoning and procedural complications Vascular Injury	0.00% 0/30 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	10.0% 3/30 • Number of events 3 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Vascular disorders Vasospasm	10.0% 3/30 • Number of events 3 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	6.7% 2/30 • Number of events 2 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Gastrointestinal disorders Vomiting	43.3% 13/30 • Number of events 14 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.	36.7% 11/30 • Number of events 12 • Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.