Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-22 @ 8:30 AM
Study NCT ID:
NCT02139969
Status:
COMPLETED
Last Update Posted:
2020-11-09
First Post:
2014-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
GreenLight XPS Laser System Retrospective Chart Review
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': 'laura.olson2@bsci.com', 'phone': '9529306428', 'title': 'Laura Olson, Clinical Project Manager', 'organization': 'Boston Scientific Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.', 'eventGroups': [{'id': 'EG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System', 'otherNumAtRisk': 956, 'otherNumAffected': 182, 'seriousNumAtRisk': 956, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Urinary Incontinence - De Novo Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Incontinence - De Novo Urge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erectile Dysfunction - De Novo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder Neck Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritative Voiding Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 39, 'numAffected': 39}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urethral Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Incontinence - Worsening Urge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erectile Dysfunction - Worsening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematospermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematuria - Gross', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Clot Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrhthmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retrograde Ejaculation - De Novo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urethral Stricture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insufficient Tissue Removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Malfunction of XPS Fiber', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Reobstruction Due to Prostate Regrowth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Excessive Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraoperative Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Perforation - Prostate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Failure / Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sloughing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Intraoperative Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder Neck Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematuria - Gross', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritative Voiding Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Clot Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Reobstruction Due to Prostate Regrowth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 956, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'International Prostate Symptom Score (IPSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '572', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System'}], 'classes': [{'categories': [{'title': 'Score of <=8', 'measurements': [{'value': '437', 'groupId': 'OG000'}]}, {'title': 'Score of 9-21', 'measurements': [{'value': '118', 'groupId': 'OG000'}]}, {'title': 'Score of >21', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months post-procedure', 'description': 'Evaluate the proportion of subjects who have mild or no BPH symptoms at six months post-procedure; e.g. an IPSS of eight or less at 6-month follow-up. An IPSS of eight or less indicates the subject is asymptomatic or has mild symptoms, a score of 9-21 indicates the subject has moderate symptoms, and a score of \\>21 indicates the subject has severe symptoms. IPSS scores can range from 0-35.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was retrospective chart review of available data collected in the medical records. The intention was to collect and analyze data through five years post-procedure; however, the data collected was minimal. Results posted here are reflective of the results that have been published (through 6-months).'}, {'type': 'PRIMARY', 'title': 'Occurrence of Adverse Events Related to the Study Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System'}], 'classes': [{'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '365 Days', 'description': 'Treatment-related adverse events include:\n\n* Event related to the study device or procedure\n* Intra-operative adverse event related to the study device or procedure\n* Serious adverse events related to the study device or procedure\n\nThe number of events as well as the number and percentage of subjects with the event will be calculated.', 'unitOfMeasure': 'Treatment-related Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with a treatment-related adverse event.'}, {'type': 'SECONDARY', 'title': 'Characteristics of the Study Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '956', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System'}], 'classes': [{'title': 'Length of Procedure (minutes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '906', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.1', 'spread': '28.6', 'groupId': 'OG000'}]}]}, {'title': 'Lasing Time (minutes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.2', 'spread': '18.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.', 'description': 'Summary of the study procedure, including length of procedure and lasing time', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected for this study was retrospective in nature and only data available in the medical records could be reported.'}, {'type': 'SECONDARY', 'title': 'Characteristics of the Study Procedure and Immediate Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '954', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System'}], 'classes': [{'categories': [{'measurements': [{'value': '275.8', 'spread': '180.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.', 'description': 'Summary of characteristics of the study procedure and immediate outcomes: total energy used (kJ)', 'unitOfMeasure': 'kJ', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected for this study was retrospective in nature and only data available in the medical records could be reported.'}, {'type': 'SECONDARY', 'title': 'Assess Changes in Quality of Life Related to BPH Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '956', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through six months post-procedure', 'description': 'Summarize IPSS-QOL from baseline through six months post-procedure for all data available during the retrospective review. The quality of life assessment responses includes: Delighted, Pleased, Mostly Satisfied, Mixed-neither satisfied or dissatisfied, Mostly Dissatisfied, Unhappy, or Terrible (range of 0 to 6).The results presented below represent the change from baseline to six months post-procedure for any response. Lower scores indicate a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was retrospective chart review of available data collected in the medical records. The intention was to collect and analyze data through five years post-procedure; however, the data collected was minimal. Results posted here are reflective of the results that have been published (through 6-months).'}, {'type': 'SECONDARY', 'title': 'Assess Changes in Objective Measures of Urologic Function.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '956', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System'}], 'classes': [{'title': 'Peak Flow Rate (Qmax) Baseline (ml/sec)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '707', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '5.7', 'groupId': 'OG000'}]}]}, {'title': 'Qmax 6 months (ml/sec)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.0', 'spread': '8.9', 'groupId': 'OG000'}]}]}, {'title': 'Qmax Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.9', 'spread': '10.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through six months post-procedure.', 'description': 'Changes in objective measures of urologic function from baseline through six months post-procedure using Peak Flow Rate (Qmax)', 'unitOfMeasure': 'ml/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was retrospective chart review of available data collected in the medical records. The intention was to collect and analyze data through five years post-procedure; however, the data collected was minimal. Results posted here are reflective of the results that have been published (through 6-months).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ER Visits, Hospital Admissions, and Surgical Re-treatments for Treatment-related Adverse Events Up to 90 Days Post-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '956', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System'}], 'classes': [{'title': 'ER Visit 30 Days', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'ER Visit 90 Days', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Hospital Admission 30 Days', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Hospital Admission 90 Days', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Surgical Re-treatment 90 Days', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 90 days post-procedure.', 'description': '* Emergency room visit for an adverse event related to the study device or procedure within 90 days of procedure\n* Hospital admission for an adverse event related to the study device or procedure within 90 days of procedure\n* Surgical intervention for an adverse event related to the study device or procedure within 90 days of procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected for this study was retrospective in nature and only data available in the medical records could be reported. Results presented are number of subjects.'}, {'type': 'SECONDARY', 'title': 'Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '956', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System'}], 'classes': [{'title': 'Incontinence, Stress 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '898', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '1.7'}]}]}, {'title': 'Incontinence, Urge 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '898', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '1.7'}]}]}, {'title': 'Incontinence, Stress 180 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '850', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '2.3'}]}]}, {'title': 'Incontinence, Urge 180 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '851', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '2.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days, 180 days', 'description': 'The percentage (count/n) of subjects with an ongoing urinary incontinence event at 90 and 180 days post-procedure. An incontinence event is considered ongoing if the onset was on or before the specified time point and the event is either unresolved or resolved after that time point.', 'unitOfMeasure': 'percentage of incontinence events', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was retrospective chart review of available data collected in the medical records. The intention was to collect and analyze data through five years post-procedure; however, the data collected was minimal. Results posted here are reflective of the results that have been published (through 6-months).'}, {'type': 'SECONDARY', 'title': 'Assess the Occurrence of Surgical Retreatment for BPH in GreenLight XPS Patients.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '955', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System'}], 'classes': [{'title': 'Reobstruction due to prostate regrowth', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Insufficient tissue removal', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Procedure through five years post-procedure.', 'description': 'Number of surgical re-treatment for BPH as a result of prostate tissue regrowth or insufficient prostatic tissue removal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected for this study was retrospective in nature and only data available in the medical records could be reported.'}, {'type': 'SECONDARY', 'title': 'Characteristics of the Study Procedure and Immediate Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '709', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '14.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.', 'description': 'Summarize characteristics of the study procedure and immediate outcomes: length of catheterization', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected for this study was retrospective in nature and only data available in the medical records could be reported.'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '817', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '6.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The number of days from admission through discharge from the medical facility will be measured.', 'description': 'Summarize length of hospital stay (in days) from admission through discharge', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected for this study was retrospective in nature and only data available in the medical records could be reported.'}, {'type': 'SECONDARY', 'title': 'Type of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '954', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System'}], 'classes': [{'title': 'Admission Type: Outpatient', 'categories': [{'measurements': [{'value': '674', 'groupId': 'OG000'}]}]}, {'title': 'Admission Type: Outpatient overnight stay', 'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000'}]}]}, {'title': 'Admission Type: inpatient', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data will be collected during the time of their hospital stay from admission through discharge', 'description': 'Summarize characteristics of the type of hospital stay (in-patient vs out-patient with an overnight stay)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected for this study was retrospective in nature and only data available in the medical records could be reported.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Stratified by Number of Fibers Used During Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '953', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System'}], 'classes': [{'title': 'Number of Fibers Used: 1', 'categories': [{'measurements': [{'value': '873', 'groupId': 'OG000'}]}]}, {'title': 'Number of Fibers Used: 2', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Number of Fibers Used: >=3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.', 'description': 'Summarize characteristics of the study procedure and immediate outcomes: number of fibers used', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected for this study was retrospective in nature and only data available in the medical records could be reported.'}, {'type': 'SECONDARY', 'title': 'Assess Changes in Objective Measures of Urologic Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '956', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System'}], 'classes': [{'title': 'PVR Baseline (ml)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '811', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '204.3', 'spread': '221.2', 'groupId': 'OG000'}]}]}, {'title': 'PVR 6 Months (ml)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.1', 'spread': '95.2', 'groupId': 'OG000'}]}]}, {'title': 'PVR Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-172', 'spread': '215.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through six months post-procedure', 'description': 'Changes in objective measures of urologic function from baseline through six months post-procedure using post void residual', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was retrospective chart review of available data collected in the medical records. The intention was to collect and analyze data through five years post-procedure; however, the data collected was minimal. Results posted here are reflective of the results that have been published (through 6-months).'}, {'type': 'SECONDARY', 'title': 'Changes in Objective Measures of Urologic Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '956', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System'}], 'classes': [{'title': 'Prostate Volume (g) Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76.0', 'spread': '49.0', 'groupId': 'OG000'}]}]}, {'title': 'Prostate Volume (g) 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.0', 'spread': '36.2', 'groupId': 'OG000'}]}]}, {'title': 'Prostate Volume (g) Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31.8', 'spread': '38.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through six months post-procedure.', 'description': 'Changes in objective measures of urologic function from baseline through six months post-procedure using prostate volume', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was retrospective chart review of available data collected in the medical records. The intention was to collect and analyze data through five years post-procedure; however, the data collected was minimal. Results posted here are reflective of the results that have been published (through 6-months).'}, {'type': 'SECONDARY', 'title': 'Assess Changes in Objective Measures of Urologic Function.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '956', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System'}], 'classes': [{'title': 'PSA (ng/ml) Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '639', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '7.8', 'groupId': 'OG000'}]}]}, {'title': 'PSA (ng/ml) 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '7.6', 'groupId': 'OG000'}]}]}, {'title': 'PSA (ng/ml) Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '7.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline through six months post-procedure.', 'description': 'Changes in objective measures of urologic function from baseline through six months post-procedure using prostate specific antigen', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was retrospective chart review of available data collected in the medical records. The intention was to collect and analyze data through five years post-procedure; however, the data collected was minimal. Results posted here are reflective of the results that have been published (through 6-months).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of men with BPH using the GreenLight XPS Laser System and the MoXy fiber'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '956'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '956'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '956', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.6', 'spread': '9.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '956', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '199', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '757', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 956}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-16', 'studyFirstSubmitDate': '2014-05-13', 'resultsFirstSubmitDate': '2016-06-07', 'studyFirstSubmitQcDate': '2014-05-14', 'lastUpdatePostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-16', 'studyFirstPostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Prostate Symptom Score (IPSS)', 'timeFrame': '6 months post-procedure', 'description': 'Evaluate the proportion of subjects who have mild or no BPH symptoms at six months post-procedure; e.g. an IPSS of eight or less at 6-month follow-up. An IPSS of eight or less indicates the subject is asymptomatic or has mild symptoms, a score of 9-21 indicates the subject has moderate symptoms, and a score of \\>21 indicates the subject has severe symptoms. IPSS scores can range from 0-35.'}, {'measure': 'Occurrence of Adverse Events Related to the Study Treatment.', 'timeFrame': '365 Days', 'description': 'Treatment-related adverse events include:\n\n* Event related to the study device or procedure\n* Intra-operative adverse event related to the study device or procedure\n* Serious adverse events related to the study device or procedure\n\nThe number of events as well as the number and percentage of subjects with the event will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Characteristics of the Study Procedure', 'timeFrame': 'Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.', 'description': 'Summary of the study procedure, including length of procedure and lasing time'}, {'measure': 'Characteristics of the Study Procedure and Immediate Outcomes', 'timeFrame': 'Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.', 'description': 'Summary of characteristics of the study procedure and immediate outcomes: total energy used (kJ)'}, {'measure': 'Assess Changes in Quality of Life Related to BPH Symptoms.', 'timeFrame': 'Baseline through six months post-procedure', 'description': 'Summarize IPSS-QOL from baseline through six months post-procedure for all data available during the retrospective review. The quality of life assessment responses includes: Delighted, Pleased, Mostly Satisfied, Mixed-neither satisfied or dissatisfied, Mostly Dissatisfied, Unhappy, or Terrible (range of 0 to 6).The results presented below represent the change from baseline to six months post-procedure for any response. Lower scores indicate a better outcome.'}, {'measure': 'Assess Changes in Objective Measures of Urologic Function.', 'timeFrame': 'Baseline through six months post-procedure.', 'description': 'Changes in objective measures of urologic function from baseline through six months post-procedure using Peak Flow Rate (Qmax)'}, {'measure': 'Number of Participants With ER Visits, Hospital Admissions, and Surgical Re-treatments for Treatment-related Adverse Events Up to 90 Days Post-Procedure', 'timeFrame': 'Up to 90 days post-procedure.', 'description': '* Emergency room visit for an adverse event related to the study device or procedure within 90 days of procedure\n* Hospital admission for an adverse event related to the study device or procedure within 90 days of procedure\n* Surgical intervention for an adverse event related to the study device or procedure within 90 days of procedure'}, {'measure': 'Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence', 'timeFrame': '90 days, 180 days', 'description': 'The percentage (count/n) of subjects with an ongoing urinary incontinence event at 90 and 180 days post-procedure. An incontinence event is considered ongoing if the onset was on or before the specified time point and the event is either unresolved or resolved after that time point.'}, {'measure': 'Assess the Occurrence of Surgical Retreatment for BPH in GreenLight XPS Patients.', 'timeFrame': 'Procedure through five years post-procedure.', 'description': 'Number of surgical re-treatment for BPH as a result of prostate tissue regrowth or insufficient prostatic tissue removal.'}, {'measure': 'Characteristics of the Study Procedure and Immediate Outcomes', 'timeFrame': 'Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.', 'description': 'Summarize characteristics of the study procedure and immediate outcomes: length of catheterization'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'The number of days from admission through discharge from the medical facility will be measured.', 'description': 'Summarize length of hospital stay (in days) from admission through discharge'}, {'measure': 'Type of Hospital Stay', 'timeFrame': 'Data will be collected during the time of their hospital stay from admission through discharge', 'description': 'Summarize characteristics of the type of hospital stay (in-patient vs out-patient with an overnight stay)'}, {'measure': 'Number of Participants Stratified by Number of Fibers Used During Procedure', 'timeFrame': 'Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.', 'description': 'Summarize characteristics of the study procedure and immediate outcomes: number of fibers used'}, {'measure': 'Assess Changes in Objective Measures of Urologic Function', 'timeFrame': 'Baseline through six months post-procedure', 'description': 'Changes in objective measures of urologic function from baseline through six months post-procedure using post void residual'}, {'measure': 'Changes in Objective Measures of Urologic Function', 'timeFrame': 'Baseline through six months post-procedure.', 'description': 'Changes in objective measures of urologic function from baseline through six months post-procedure using prostate volume'}, {'measure': 'Assess Changes in Objective Measures of Urologic Function.', 'timeFrame': 'From baseline through six months post-procedure.', 'description': 'Changes in objective measures of urologic function from baseline through six months post-procedure using prostate specific antigen'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to gain information on the safety, efficacy, and quality of life in subjects who have had the GreenLight XPS procedure.', 'detailedDescription': 'This is a retrospective chart review conducted at six centers in the United States and Canada. This review will evaluate the safety and efficacy of GreenLight XPS in subjects who received treatment on or after 01-Aug-2010.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of males who have had the GreenLight XPS procedure with the MoXy fiber on or after 01-Aug-2010. The cohort will be selected from six pre-selected urology clinics in the US and one pre-selected urology clinic in Canada.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men who have had a GreenLight XPS procedure with a MoXy Fiber since 01-Aug-2010.\n\nExclusion Criteria:\n\n* Subject has had prior radiation.\n* Subject has a diagnosis of neurogenic bladder confirmed by urodynamic studies (BOO, detrusor overactivity (DO), impaired detrusor contractor (IDC))\n* Subject has a neurologic disorder that would impact bladder function (MS, Parkinson, Spinal Cord Injury) (note: Stroke patients not excluded)\n* Subject has an artificial urinary sphincter'}, 'identificationModule': {'nctId': 'NCT02139969', 'briefTitle': 'GreenLight XPS Laser System Retrospective Chart Review', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'GreenLight XPS Laser System for the Treatment of Benign Prostatic Hyperplasia: Evaluation of Safety, Efficacy, and Quality of Life Through Retrospective Chart Review', 'orgStudyIdInfo': {'id': 'PE1401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GreenLight XPS Laser System', 'description': 'Treatment of BPH in men using the GreenLight XPS Laser System and the MoXy fiber', 'interventionNames': ['Device: GreenLight XPS Laser System']}], 'interventions': [{'name': 'GreenLight XPS Laser System', 'type': 'DEVICE', 'armGroupLabels': ['GreenLight XPS Laser System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'El Camino Urology Medical Group, Inc.', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Urology', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '48186', 'city': 'Westland', 'state': 'Michigan', 'country': 'United States', 'facility': 'Affiliates Division, Comprehensive Urology', 'geoPoint': {'lat': 42.3242, 'lon': -83.40021}}, {'zip': '77027', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Metro Urology', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23462', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Urology of Virginia, PLLC', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'University of Montreal Hospital Center', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Mahmood A. Hai, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliates Division, Comprehensive Urology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}