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| ID | Type | Description | Link |
|---|---|---|---|
| ONC-PM-022005 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uterine Fibroid Embolization (UFE) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24-hours post study procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Shalansky-Goldberg, MD | University of Pennsylvania | Principal Investigator |
| Pamela Grady, Ph.D | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104-3246 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24788209 | Derived | Shlansky-Goldberg RD, Rosen MA, Mondschein JI, Stavropoulos SW, Trerotola SO, Diaz-Cartelle J. Comparison of polyvinyl alcohol microspheres and tris-acryl gelatin microspheres for uterine fibroid embolization: results of a single-center randomized study. J Vasc Interv Radiol. 2014 Jun;25(6):823-32. doi: 10.1016/j.jvir.2014.03.009. Epub 2014 Apr 29. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Contour SE™ Microspheres | Device | 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 | Device | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. |
|
| 24 hours after study procedure |
| 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. | 24 hours after study procedure |
| 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. | During the study procedure (measured in minutes) |
| Procedure Time | Procedure time is the time in minutes of the first arterial puncture to time of hemostasis (stopping bleeding) | During the study procedure (measured in minutes) |
| 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. | During the hospitalization stay post UFE |
| 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) | Baseline |
| 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) | 3-months |
| 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). | 12 months |
| 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. | Baseline |
| 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. | 3 months |
| 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. | 12 months |
| Embosphere Microspheres |
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Embosphere Microspheres | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Two participants in the Embosphere group had missing values for Race. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Previous or concurrent gynecological disease(s) | Number | partcipants |
| ||||||||||||||||||
| Fibroid Related Symptoms | Fibroid related symptoms is collected on the baseline CRF. A participant may have multiple symptoms present, thus the number may not add up to 30 per group or 60 total. The analysis indicates the number of participants with each symptom, thus the sum for all categories in the arm/group does not equal the overall number of participants in the group. | Number | particpants |
| |||||||||||||||||
| Number of fibroids present greater than 2cm | Number | particpants |
| ||||||||||||||||||
| Number of fibroids present less than 2 cm | Number | participants |
| ||||||||||||||||||
| Type of fibroid present | The type of fibroid present is determined from the baseline MRI. A participant may have more than one type of fibroid present, thus the number may not add up to 30 per group or 60 total. The analysis indicates the number of participants with each type of fibroid, thus the sum for all categories in the arm/group does not equal the overall number of participants in the group. | Number | participants |
| |||||||||||||||||
| Dominant fibroid volume | Mean | Standard Deviation | cm^3 |
| |||||||||||||||||
| Uterine Volume | Mean | Standard Deviation | cm^3 |
| |||||||||||||||||
| Maximal thickness of junctional zone | Mean | Standard Deviation | mm |
| |||||||||||||||||
| Maximal thickness of the endometrium | Mean | Standard Deviation | mm |
| |||||||||||||||||
| Minimal thickness of the myometrium | Mean | Standard Deviation | mm |
| |||||||||||||||||
| Concomitant adenomyosis | This measure contains the number of subjects with concomitant adenomyosis. If concomitant adenomyosis was noted, it was further classified as focal or diffuse. Not all subjects had concomitant adenomyosis noted. The sum for all categories in the arm/group does not equal the overall number of participants in the group, because the value only indicates if the measure was present. | Number | participants |
| |||||||||||||||||
| Presence of endometrial scar | Number | participants |
| ||||||||||||||||||
| Presence of myometrial scar | Number | participants |
| ||||||||||||||||||
| Assessment of myometrial perfusion | Number | participants |
| ||||||||||||||||||
| Ovaries seen | Number | participants |
| ||||||||||||||||||
| Adnexal Pathology | This measure contains the number of subjects with adnexal pathology noted. If adnexal pathology was noted, it was further classified to be endometrioma/endometriosis, cyst, or other. Not all subjects had adnexal pathology noted. The sum for all categories in the arm/group does not equal the overall number of participants in the group. | Number | participants |
| |||||||||||||||||
| Obvious contribution to the uterine blood supply from the ovarian artery | Number | participants |
| ||||||||||||||||||
| Maximal Thickness of the myometrium | Mean | Standard Deviation | mm |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Number | participants | 24-hours post study procedure |
|
|
| ||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | cm | 24 hours after study procedure |
|
| ||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | cm | 24 hours after study procedure |
|
| ||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | minutes | During the study procedure (measured in minutes) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Procedure Time | Procedure time is the time in minutes of the first arterial puncture to time of hemostasis (stopping bleeding) | Posted | Mean | Standard Deviation | minutes | During the study procedure (measured in minutes) |
|
| ||||||||||||||||||||||||||||||
| 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. | Posted | Number | events | During the hospitalization stay post UFE |
|
| |||||||||||||||||||||||||||||||
| 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) | Posted | Mean | Standard Deviation | Scores on a scale | Baseline |
|
| ||||||||||||||||||||||||||||||
| 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) | Posted | Mean | Standard Deviation | Scores on a scale | 3-months |
|
| ||||||||||||||||||||||||||||||
| 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). | Posted | Mean | Standard Deviation | Scores on a scale | 12 months |
|
| ||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline |
|
| ||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | Scores | 3 months |
|
| ||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | Scores on a scale | 12 months |
|
|
Adverse events were collected at baseline, 24 hours post-procedure, 3 month follow-up, and 12 month follow-up.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 1 | 30 | 25 | 30 | ||
| EG001 | Embosphere Microspheres | Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. | 3 | 30 | 22 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endometriosis | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Vaginal Exfoliation | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Vascular Injury | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Vasospasm | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ana Becker / Sr. Clinical Program Manager | Boston Scientific | 651-581-4605 | Ana.Becker@bsci.com |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D014594 | Uterine Neoplasms |
| D008595 | Menorrhagia |
| D018231 | Leiomyomatosis |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| # of participants without concurrent gyneco diseas |
|
| Bulk/pressure |
|
| Pelvic Pain |
|
| Other |
|
| 1 fibroid |
|
| 2 fibroids |
|
| 3 fibroids |
|
| 4 fibroids |
|
| 5 fibroids |
|
| 6 fibroids |
|
| 7-10 fibroids |
|
| >10 fibroids |
|
| 1 fibroid |
|
| 2 fibroids |
|
| 3 fibroids |
|
| 4 fibroids |
|
| 5 fibroids |
|
| 6 fibroids |
|
| 7-10 fibroids |
|
| >10 fibroids |
|
| Subserosal |
|
| Intramural |
|
| Transmural |
|
| Other, specify |
|
| Cannot determine |
|
| Diffuse |
|
| Cannot Determine |
|
| No |
|
| No |
|
| Mildly Decreased |
|
| Moderately Decreased |
|
| Severly Decreased/Infarcted |
|
| No |
|
| Cyst |
|
| Other |
|
| No |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|