Leiomyoma, Leiomyomatosis, Menorrhagia, Uterine Fibroids, Uterine Neoplasms
Conditions
Keywords
Leiomyoma, Uterine Fibroids, Uterine Fibroid Embolization (UFE), Uterine Artery Embolization (UAE), Uterine Neoplasms, Menorrhagia
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.
Interventions
PROCEDUREUterine 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.
DEVICEContour 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
DEVICEEmbosphere® Microspheres
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| 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) |
| 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. |
| 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| Embosphere Microspheres Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Total | Contour SE Microspheres | Embosphere Microspheres |
|---|---|---|---|
| Adnexal Pathology Cyst | 5 participants | 3 participants | 2 participants |
| Adnexal Pathology Endometrioma/Endometriosis | 1 participants | 0 participants | 1 participants |
| Adnexal Pathology Other | 2 participants | 2 participants | 0 participants |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 30 Participants | 30 Participants |
| Age Continuous | 42.8 years STANDARD_DEVIATION 5.3 | 43.9 years STANDARD_DEVIATION 5 | 41.7 years STANDARD_DEVIATION 5.4 |
| Assessment of myometrial perfusion Mildly Decreased | 1 participants | 0 participants | 1 participants |
| Assessment of myometrial perfusion Moderately Decreased | 0 participants | 0 participants | 0 participants |
| Assessment of myometrial perfusion Normal | 58 participants | 30 participants | 28 participants |
| Assessment of myometrial perfusion Severly Decreased/Infarcted | 0 participants | 0 participants | 0 participants |
| Concomitant adenomyosis Cannot Determine | 0 participants | 0 participants | 0 participants |
| Concomitant adenomyosis Diffuse | 4 participants | 2 participants | 2 participants |
| Concomitant adenomyosis Focal | 12 participants | 7 participants | 5 participants |
| Dominant fibroid volume | 172.2 cm^3 STANDARD_DEVIATION 232.5 | 203.3 cm^3 STANDARD_DEVIATION 275.1 | 141.1 cm^3 STANDARD_DEVIATION 179.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 21 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants | 9 Participants | 11 Participants |
| Fibroid Related Symptoms Abnormal Bleeding | 55 particpants | 28 particpants | 27 particpants |
| Fibroid Related Symptoms Bulk/pressure | 45 particpants | 20 particpants | 25 particpants |
| Fibroid Related Symptoms Other | 18 particpants | 8 particpants | 10 particpants |
| Fibroid Related Symptoms Pelvic Pain | 45 particpants | 22 particpants | 23 particpants |
| Maximal thickness of junctional zone | 11.2 mm STANDARD_DEVIATION 7.2 | 11.4 mm STANDARD_DEVIATION 6.6 | 10.9 mm STANDARD_DEVIATION 7.9 |
| Maximal thickness of the endometrium | 8.1 mm STANDARD_DEVIATION 3.2 | 7.3 mm STANDARD_DEVIATION 2.8 | 8.9 mm STANDARD_DEVIATION 3.3 |
| Maximal Thickness of the myometrium | 25.9 mm STANDARD_DEVIATION 7.8 | 26.8 mm STANDARD_DEVIATION 8.1 | 25.0 mm STANDARD_DEVIATION 7.4 |
| Minimal thickness of the myometrium | 10.3 mm STANDARD_DEVIATION 4.7 | 11.2 mm STANDARD_DEVIATION 5.1 | 9.5 mm STANDARD_DEVIATION 4.2 |
| Number of fibroids present greater than 2cm 0 fibroids | 1 particpants | 1 particpants | 0 particpants |
| Number of fibroids present greater than 2cm >10 fibroids | 10 particpants | 3 particpants | 7 particpants |
| Number of fibroids present greater than 2cm 1 fibroid | 4 particpants | 1 particpants | 3 particpants |
| Number of fibroids present greater than 2cm 2 fibroids | 7 particpants | 2 particpants | 5 particpants |
| Number of fibroids present greater than 2cm 3 fibroids | 14 particpants | 10 particpants | 4 particpants |
| Number of fibroids present greater than 2cm 4 fibroids | 4 particpants | 2 particpants | 2 particpants |
| Number of fibroids present greater than 2cm 5 fibroids | 4 particpants | 2 particpants | 2 particpants |
| Number of fibroids present greater than 2cm 6 fibroids | 5 particpants | 3 particpants | 2 particpants |
| Number of fibroids present greater than 2cm 7-10 fibroids | 11 particpants | 6 particpants | 5 particpants |
| Number of fibroids present less than 2 cm 0 fibroids | 6 participants | 3 participants | 3 participants |
| Number of fibroids present less than 2 cm >10 fibroids | 16 participants | 7 participants | 9 participants |
| Number of fibroids present less than 2 cm 1 fibroid | 5 participants | 2 participants | 3 participants |
| Number of fibroids present less than 2 cm 2 fibroids | 3 participants | 2 participants | 1 participants |
| Number of fibroids present less than 2 cm 3 fibroids | 4 participants | 3 participants | 1 participants |
| Number of fibroids present less than 2 cm 4 fibroids | 6 participants | 4 participants | 2 participants |
| Number of fibroids present less than 2 cm 5 fibroids | 6 participants | 2 participants | 4 participants |
| Number of fibroids present less than 2 cm 6 fibroids | 6 participants | 3 participants | 3 participants |
| Number of fibroids present less than 2 cm 7-10 fibroids | 8 participants | 4 participants | 4 participants |
| Obvious contribution to the uterine blood supply from the ovarian artery No | 59 participants | 30 participants | 29 participants |
| Obvious contribution to the uterine blood supply from the ovarian artery Yes | 1 participants | 0 participants | 1 participants |
| Ovaries seen No | 2 participants | 1 participants | 1 participants |
| Ovaries seen Yes | 58 participants | 29 participants | 29 participants |
| Presence of endometrial scar No | 60 participants | 30 participants | 30 participants |
| Presence of endometrial scar Yes | 0 participants | 0 participants | 0 participants |
| Presence of myometrial scar No | 46 participants | 23 participants | 23 participants |
| Presence of myometrial scar Yes | 14 participants | 7 participants | 7 participants |
| Previous or concurrent gynecological disease(s) # of participants with concurrent gyneco disease | 12 partcipants | 5 partcipants | 7 partcipants |
| Previous or concurrent gynecological disease(s) # of participants without concurrent gyneco diseas | 48 partcipants | 25 partcipants | 23 partcipants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 41 Participants | 21 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 13 Participants | 7 Participants | 6 Participants |
| Region of Enrollment United States | 60 participants | 30 participants | 30 participants |
| Sex: Female, Male Female | 60 Participants | 30 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Type of fibroid present Cannot determine | 0 participants | 0 participants | 0 participants |
| Type of fibroid present Intramural | 56 participants | 28 participants | 28 participants |
| Type of fibroid present Other, specify | 0 participants | 0 participants | 0 participants |
| Type of fibroid present Submucosal | 36 participants | 16 participants | 20 participants |
| Type of fibroid present Subserosal | 50 participants | 26 participants | 24 participants |
| Type of fibroid present Transmural | 31 participants | 14 participants | 17 participants |
| Uterine Volume | 1514.2 cm^3 STANDARD_DEVIATION 1214.5 | 1536.7 cm^3 STANDARD_DEVIATION 937.3 | 1491.6 cm^3 STANDARD_DEVIATION 1456.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 30 | 22 / 30 |
| serious Total, serious adverse events | 1 / 30 | 3 / 30 |
Outcome results
Primary
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).
Time frame: 24-hours post study procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contour SE Microspheres | Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI) | 29 participants |
| Embosphere Microspheres | Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI) | 29 participants |
Secondary
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.
Time frame: During the hospitalization stay post UFE
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contour SE Microspheres | Any Adverse Events That the Participant Experienced | 68 events |
| Embosphere Microspheres | Any Adverse Events That the Participant Experienced | 58 events |
Secondary
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.
Time frame: During the study procedure (measured in minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contour SE Microspheres | Fluoroscopy Time | 31.1 minutes | Standard Deviation 19.4 |
| Embosphere Microspheres | Fluoroscopy Time | 24.9 minutes | Standard Deviation 8.7 |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contour SE Microspheres | Health Related Quality of Life (HRQL)Subscores | 42.1 Scores on a scale | Standard Deviation 20.2 |
| Embosphere Microspheres | Health Related Quality of Life (HRQL)Subscores | 42.0 Scores on a scale | Standard Deviation 23.7 |
Secondary
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contour SE Microspheres | Health Related Quality of Life Subscores | 89.8 Scores on a scale | Standard Deviation 14.5 |
| Embosphere Microspheres | Health Related Quality of Life Subscores | 89.9 Scores on a scale | Standard Deviation 11.5 |
Secondary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contour SE Microspheres | Health Related Quality of Life Subscores | 90.0 Scores | Standard Deviation 13.1 |
| Embosphere Microspheres | Health Related Quality of Life Subscores | 90.0 Scores | Standard Deviation 11.7 |
Secondary
Procedure Time
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contour SE Microspheres | Procedure Time | 102 minutes | Standard Deviation 49.9 |
| Embosphere Microspheres | Procedure Time | 95.6 minutes | Standard Deviation 39.6 |
Secondary
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)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contour SE Microspheres | Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score | 64.2 Scores on a scale | Standard Deviation 20.6 |
| Embosphere Microspheres | Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score | 65.1 Scores on a scale | Standard Deviation 20.3 |
Secondary
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)
Time frame: 3-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contour SE Microspheres | Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score | 16.3 Scores on a scale | Standard Deviation 12.1 |
| Embosphere Microspheres | Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score | 22.7 Scores on a scale | Standard Deviation 20.5 |
Secondary
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).
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contour SE Microspheres | Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score | 18.0 Scores on a scale | Standard Deviation 15.5 |
| Embosphere Microspheres | Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score | 22.9 Scores on a scale | Standard Deviation 17.8 |
Secondary
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.
Time frame: 24 hours after study procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contour SE Microspheres | Visual Analog Scale (VAS) Maximum Level of Nausea | 5.5 cm | Standard Deviation 3 |
| Embosphere Microspheres | Visual Analog Scale (VAS) Maximum Level of Nausea | 4.8 cm | Standard Deviation 3.2 |
Secondary
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.
Time frame: 24 hours after study procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contour SE Microspheres | Visual Analog Scale (VAS) Maximum Level of Pain | 6.0 cm | Standard Deviation 2.9 |
| Embosphere Microspheres | Visual Analog Scale (VAS) Maximum Level of Pain | 5.6 cm | Standard Deviation 2.8 |