Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-28 @ 10:04 PM
Study NCT ID:
NCT02396420
Status:
TERMINATED
Last Update Posted:
2018-11-06
First Post:
2015-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cynthia.toot@holy-cross.com', 'phone': '954-267-6626', 'title': 'Cynthia Toot ARNP', 'organization': 'South Florida Medical Imaging'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Enrollment was limited due to early study termination. This was a result of Embosphere Microspheres (investigational product for this IDE) receiving FDA clearance for embolization of prostatic arteries for symptomatic benign prostatic hyperplasia.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) occurring during the clinical trial and the protocol-defined 12-month follow-up period were recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'This is a single arm study. All subjects with eligibility confirmed during the screening period and completing Visit 1 (Prostate Artery Embolization) within 4 weeks of screening are included in the arm.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Catheter site burning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Bladder irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Allergic Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the International Prostate Symptom Score (IPSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The outcome measure was the International Prostate Symptom Score (IPSS). The IPSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). A higher score means a worse outcome.', 'unitOfMeasure': 'units on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE) and completed the study thru Visit 5 (12 month follow-up).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Prostate Size, as Determined by MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.'}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 12 months', 'description': 'Prostate size was determined by measuring the prostate with magnetic resonance imaging (MRI) and calculating length x width x height x pi/6.', 'unitOfMeasure': 'grams', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE) and completed the study thru Visit 5 (12 month follow-up).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peak Urine Flow Rate (Qmax) Determined by Urodynamic Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.'}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.'}], 'timeFrame': '12 Months', 'description': "Peak urine flow rate (Qmax) is the greatest volumetric flow rate of urine during urination, measured as the quantity of urine excreted in a specified period of time (per second or per minute). Qmax has become a primary objective parameter of treatment outcomes for various surgical and medical therapies for BPH. Unlike other prominent parameters of treatment outcome, Qmax responds minimally to placebo, making it an objective tool when evaluating a patient's response to therapy.", 'reportingStatus': 'POSTED', 'populationDescription': 'The one subject who completed the study thru Visit 5 refused to undergo urodynamic testing at Visit 5. As a result the Qmax was not obtained. This was reported as a protocol deviation in the study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Post Void Residual Volume (PVR) as Determined by Urodynamic Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.'}], 'analyses': [{'groupIds': ['OG000'], 'groupDescription': 'Statistical analysis was not performed as this data was not available for any subjects in the analysis population.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Statistical analysis was not performed as this data was not available for any subjects in the analysis population.', 'otherAnalysisDescription': 'Statistical analysis was not performed as this data was not available for any subjects in the analysis population.'}], 'timeFrame': '12 Months', 'description': 'Post void residual is a measurement of the amount of urine left in the bladder after voiding. It has traditionally been used to evaluate efficacy of treatment efforts. A positive response to treatment is associated with decreased PVR volumes.', 'reportingStatus': 'POSTED', 'populationDescription': 'The one subject who completed the study thru Visit 5 refused to undergo urodynamic testing at Visit 5. As a result the PVR was not obtained. This was reported as a protocol deviation in the study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Detrusor Muscle Pressure (Pdet) as Determined by Urodynamic Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.'}], 'analyses': [{'groupIds': ['OG000'], 'groupDescription': 'Statistical analysis was not performed as this data was not available for any subjects in the analysis population.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Statistical analysis was not performed as this data was not available for any subjects in the analysis population.', 'otherAnalysisDescription': 'Statistical analysis was not performed as this data was not available for any subjects in the analysis population.'}], 'timeFrame': '12 Months', 'description': 'Detrusor muscle pressure (Pdet) is important when evaluating how strong the detrusor force must be to initiate urine flow in bladder outlet obstruction. Lower Pdet values are associated with a positive response to treatment.', 'reportingStatus': 'POSTED', 'populationDescription': 'The one subject who completed the study thru Visit 5 refused to undergo urodynamic testing at Visit 5. As a result the Pdet was not obtained. This was reported as a protocol deviation in the study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erectile Function as Determined by the International Index of Erectile Function (IIEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.'}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'The outcome measure was the International Index of Erectile Function (IIEF). The 15 question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment of erectile dysfunction and treatment. It is examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. The answer to each question is given a score between 0 and 5 for a total score of 0-75 (higher score = less dysfunction). Higher scores mean better outcome.', 'unitOfMeasure': 'units on scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE) and completed the study thru Visit 5 (12 month follow-up).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Prostate Specific Antigen (PSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.26', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and12 Months', 'description': 'Serum prostate specific antigen (PSA) trends over time, may help to improve the specificity of PSA testing in men with BPH. A strong correlation has been demonstrated between prostate volume and serum PSA levels.', 'unitOfMeasure': 'ng/mL', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE) and completed the study thru Visit 5 (12 month follow-up).'}, {'type': 'SECONDARY', 'title': 'Prostate Artery Embolization (PSA) Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}, {'units': 'occurrence', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.'}], 'classes': [{'categories': [{'title': 'Catheter site burning', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Pelvic pain', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Dysuria', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Pollakiuria', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Bladder irritation', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '12 Months', 'description': 'Number of occurrences of adverse events with some relationship to the study procedure or study device. An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject and does not necessarily have to have a causal relationship with the treatment. In order to capture the most potentially relevant safety information during the study, AEs were assessed at each visit. AEs occurring during the clinical trial and the protocol-defined 12-month follow-up period were reported.', 'unitOfMeasure': 'occurrence', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'occurrence', 'denomUnitsSelected': 'occurrence', 'populationDescription': 'Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.'}, {'type': 'SECONDARY', 'title': 'Overall Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.'}], 'classes': [{'title': 'Catheter site burning', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pelvic pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Dysuria', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pollakiuria', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Bladder irritation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Nasopharyngitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urinary tract infection', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Acute myocardial infarction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Acute sinusitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Allergic rhinitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.'}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'All adverse events will be assessed for severity, relationship to study treatment, subsequent treatment required, and outcome', 'unitOfMeasure': 'occurrence', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total PAE Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.'}], 'classes': [{'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000', 'lowerLimit': '130', 'upperLimit': '228'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.'}], 'paramType': 'MEAN', 'timeFrame': 'Study treatment hospitalization (expected to be less than 1 day)', 'description': 'Parameter measured during the PAE (index procedure) for informational purposes. Total PAE procedure time was defined as time of femoral artery puncture to the time of time sheath removed from femoral artery.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Fluoroscopy Time for PAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '77'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.'}], 'paramType': 'MEAN', 'timeFrame': 'Study treatment hospitalization (expected to be less than 1 day)', 'description': 'Parameter to be measured during PAE procedure, for informational purposes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Type of Contrast Media Delivered for PAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.'}], 'classes': [{'title': 'Isovue 370', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Isovue 300', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Study treatment hospitalization (expected to be less than 1 day)', 'description': 'Parameter to be measured during PAE procedure, for informational purposes', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Volume of Contrast Delivered for PAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.'}], 'classes': [{'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '260'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.'}], 'paramType': 'MEAN', 'timeFrame': 'Study treatment hospitalization (expected to be less than 1 day)', 'description': 'Parameter to be measured during PAE procedure, for informational purposes', 'unitOfMeasure': 'milliliter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Volume of Embolic Delivered for PAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '11.2'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.'}], 'paramType': 'MEAN', 'timeFrame': 'Study treatment hospitalization (expected to be less than 1 day)', 'description': 'Parameter to be measured during PAE procedure, for informational purposes', 'unitOfMeasure': 'milliliter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Origins of Prostatic Blood Supply', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.'}], 'classes': [{'title': 'Origins of blood supply right side', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1'}]}]}, {'title': 'Origins of blood supply left side', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.'}], 'paramType': 'MEAN', 'timeFrame': 'Study treatment hospitalization (expected to be less than 1 day)', 'description': 'Parameter to be measured during PAE procedure, for informational purposes', 'unitOfMeasure': 'number of vessels', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Duration of Hospitalization Post PAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.'}], 'classes': [{'categories': [{'measurements': [{'value': '1872', 'groupId': 'OG000', 'lowerLimit': '1869', 'upperLimit': '1875'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.'}], 'paramType': 'MEAN', 'timeFrame': 'Study treatment hospitalization (expected to be less than 1 day)', 'description': 'Parameter to be measured during PAE procedure, for informational purposes', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Duration of [Urinary] Catheterization Post PAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.'}], 'classes': [{'categories': [{'measurements': [{'value': '1406', 'groupId': 'OG000', 'lowerLimit': '1390', 'upperLimit': '1422'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.'}], 'paramType': 'MEAN', 'timeFrame': 'Study treatment hospitalization (expected to be less than 1 day)', 'description': 'Parameter to be measured during PAE procedure, for informational purposes', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Arm', 'description': 'Patients will receive prostate artery embolization (PAE) with Embosphere Microspheres.\n\nEmbosphere Microspheres'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': '1 Month Post PAE', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': '3 Months Post PAE', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': '6 Months Post PAE', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'comment': '12 Months Post PAE', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Following FDA and IRB approval for the study, recruitment began and the first subject was enrolled for the study on September 24, 2015. Enrollment was closed on June 29, 2017.', 'preAssignmentDetails': 'The study involved a screening period during which patient eligibility was determined. There were no screen failures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Arm', 'description': 'Prostate artery embolization (PAE) with Embosphere Microspheres.\n\nEmbosphere Microspheres'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'groupId': 'BG000', 'lowerLimit': '66', 'upperLimit': '69'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Use of 5 alpha reductase inhibitors', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Use of alpha adrenergic blockers', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Use of other medications or supplements [to treat BPH]', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Use of other BPH treatments', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'IP received FDA clearance for use in PAE as treatment for BPH.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2015-03-12', 'resultsFirstSubmitDate': '2018-06-20', 'studyFirstSubmitQcDate': '2015-03-17', 'lastUpdatePostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-09', 'studyFirstPostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total PAE Procedure Time', 'timeFrame': 'Study treatment hospitalization (expected to be less than 1 day)', 'description': 'Parameter measured during the PAE (index procedure) for informational purposes. Total PAE procedure time was defined as time of femoral artery puncture to the time of time sheath removed from femoral artery.'}, {'measure': 'Total Fluoroscopy Time for PAE', 'timeFrame': 'Study treatment hospitalization (expected to be less than 1 day)', 'description': 'Parameter to be measured during PAE procedure, for informational purposes.'}, {'measure': 'Type of Contrast Media Delivered for PAE', 'timeFrame': 'Study treatment hospitalization (expected to be less than 1 day)', 'description': 'Parameter to be measured during PAE procedure, for informational purposes'}, {'measure': 'Volume of Contrast Delivered for PAE', 'timeFrame': 'Study treatment hospitalization (expected to be less than 1 day)', 'description': 'Parameter to be measured during PAE procedure, for informational purposes'}, {'measure': 'Volume of Embolic Delivered for PAE', 'timeFrame': 'Study treatment hospitalization (expected to be less than 1 day)', 'description': 'Parameter to be measured during PAE procedure, for informational purposes'}, {'measure': 'Number of Origins of Prostatic Blood Supply', 'timeFrame': 'Study treatment hospitalization (expected to be less than 1 day)', 'description': 'Parameter to be measured during PAE procedure, for informational purposes'}, {'measure': 'Duration of Hospitalization Post PAE', 'timeFrame': 'Study treatment hospitalization (expected to be less than 1 day)', 'description': 'Parameter to be measured during PAE procedure, for informational purposes'}, {'measure': 'Duration of [Urinary] Catheterization Post PAE', 'timeFrame': 'Study treatment hospitalization (expected to be less than 1 day)', 'description': 'Parameter to be measured during PAE procedure, for informational purposes'}], 'primaryOutcomes': [{'measure': 'Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the International Prostate Symptom Score (IPSS)', 'timeFrame': '12 months', 'description': 'The outcome measure was the International Prostate Symptom Score (IPSS). The IPSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). A higher score means a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Prostate Size, as Determined by MRI', 'timeFrame': 'Baseline and 12 months', 'description': 'Prostate size was determined by measuring the prostate with magnetic resonance imaging (MRI) and calculating length x width x height x pi/6.'}, {'measure': 'Change From Baseline in Peak Urine Flow Rate (Qmax) Determined by Urodynamic Testing', 'timeFrame': '12 Months', 'description': "Peak urine flow rate (Qmax) is the greatest volumetric flow rate of urine during urination, measured as the quantity of urine excreted in a specified period of time (per second or per minute). Qmax has become a primary objective parameter of treatment outcomes for various surgical and medical therapies for BPH. Unlike other prominent parameters of treatment outcome, Qmax responds minimally to placebo, making it an objective tool when evaluating a patient's response to therapy."}, {'measure': 'Change From Baseline in Post Void Residual Volume (PVR) as Determined by Urodynamic Testing', 'timeFrame': '12 Months', 'description': 'Post void residual is a measurement of the amount of urine left in the bladder after voiding. It has traditionally been used to evaluate efficacy of treatment efforts. A positive response to treatment is associated with decreased PVR volumes.'}, {'measure': 'Change From Baseline in Detrusor Muscle Pressure (Pdet) as Determined by Urodynamic Testing', 'timeFrame': '12 Months', 'description': 'Detrusor muscle pressure (Pdet) is important when evaluating how strong the detrusor force must be to initiate urine flow in bladder outlet obstruction. Lower Pdet values are associated with a positive response to treatment.'}, {'measure': 'Change From Baseline in Erectile Function as Determined by the International Index of Erectile Function (IIEF)', 'timeFrame': '12 Months', 'description': 'The outcome measure was the International Index of Erectile Function (IIEF). The 15 question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment of erectile dysfunction and treatment. It is examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. The answer to each question is given a score between 0 and 5 for a total score of 0-75 (higher score = less dysfunction). Higher scores mean better outcome.'}, {'measure': 'Change From Baseline in Serum Prostate Specific Antigen (PSA)', 'timeFrame': 'Baseline and12 Months', 'description': 'Serum prostate specific antigen (PSA) trends over time, may help to improve the specificity of PSA testing in men with BPH. A strong correlation has been demonstrated between prostate volume and serum PSA levels.'}, {'measure': 'Prostate Artery Embolization (PSA) Related Adverse Events', 'timeFrame': '12 Months', 'description': 'Number of occurrences of adverse events with some relationship to the study procedure or study device. An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject and does not necessarily have to have a causal relationship with the treatment. In order to capture the most potentially relevant safety information during the study, AEs were assessed at each visit. AEs occurring during the clinical trial and the protocol-defined 12-month follow-up period were reported.'}, {'measure': 'Overall Adverse Events', 'timeFrame': '12 Months', 'description': 'All adverse events will be assessed for severity, relationship to study treatment, subsequent treatment required, and outcome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BPH', 'prostatic hyperplasia', 'enlarged prostate', 'benign prostatic hypertrophy'], 'conditions': ['Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate improvement in symptoms related to benign prostatic hyperplasia (BPH) in men treated with prostate artery embolization (PAE) using Embosphere Microspheres.', 'detailedDescription': 'The study will evaluate improvement in symptoms associated with benign prostatic hyperplasia (BPH) in men with prostates larger than 90 grams treated with prostate artery embolization (PAE). Symptoms will be assessed utilizing the International Prostate Symptom Score (IPSS) to evaluate change from baseline at 12 months post PAE.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient has provided signed informed consent\n* Patient is aged greater than or equal to 40 and less than or equal to 89 years of age\n* Patient has a prostate size between 90g and 200g, as determined by MRI\n* Patient has experienced lower urinary tract symptoms (LUTS) for at least 6 months prior to study enrollment\n* Patient has an IPSS score of at least 13 at baseline\n* Patient is either: refractory to medical treatment, contraindicated to medical treatment, OR refuses medical treatment\n* Patient either: refuses surgical treatment OR is contraindicated for surgical treatment\n* Patient meets ONE of the following criteria: baseline PSA \\< 4.0ng/mL (no prostate biopsy required) OR baseline PSA \\>/= 4 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy) within the prior 12 months\n\nExclusion Criteria:\n\n* History of prostate, bladder, or rectal cancer\n* History of transurethral resection of the prostate (TURP), open prostate surgery, or radiofrequency or microwave therapies\n* History of open bladder, rectosigmoid colon, or other pelvic surgery\n* Patient is unwilling to discontinue alpha blockers 1 month after study treatment\n* Patient is unwilling to discontinue 5-alph reductase inhibitors 1 month after study treatment\n* Neurogenic bladder or other neurologic disorder impacting bladder function such as Parkinson's disease, multiple sclerosis, cerebral vascular accident or diabetes\n* Any other confounding bladder or urethral pathology, including urethral stricture, bladder neck contracture, or bladder atonia\n* Active prostatitis or urinary tract infection\n* Cystolithiasis within the past 3 months\n* Serum creatinine \\> 1.7mg/dL\n* Inability to discontinue oral anticoagulant 2-5 days prior to study treatment\n* Coagulation disturbances not normalized by medical treatment\n* Iodinated contrast allergy that, in the opinion of the Investigator, cannot be adequately premedicated\n* Gelatin allergy\n* Known severe peripheral vascular disease or major iliac arterial occlusive disease\n* Interest in future fertility\n* Clinically significant cardiac arrhythmia or other cardiac disease (including congestive heart failure), uncontrolled diabetes mellitus, clinically significant respiratory disease, or known immunosuppression\n* Other condition that the Investigator believes puts the patient at risk for a complication during the procedure"}, 'identificationModule': {'nctId': 'NCT02396420', 'briefTitle': 'Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams', 'organization': {'class': 'OTHER', 'fullName': 'South Florida Medical Imaging, PA'}, 'officialTitle': 'Phase II, Single Center, Single Arm, Open Label Investigation of Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams', 'orgStudyIdInfo': {'id': 'PAE001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'Patients will receive prostate artery embolization (PAE) with Embosphere Microspheres.', 'interventionNames': ['Device: Embosphere Microspheres']}], 'interventions': [{'name': 'Embosphere Microspheres', 'type': 'DEVICE', 'armGroupLabels': ['Treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Hospital', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}], 'overallOfficials': [{'name': 'Michael Rush, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Florida Medical Imaging, Holy Cross Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Florida Medical Imaging, PA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}