Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-28 @ 10:04 PM
Study NCT ID:
NCT01500057
Status:
COMPLETED
Last Update Posted:
2018-05-14
First Post:
2011-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia
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': 'ivg9002@nyp.org', 'phone': '718-230-7788', 'title': 'Ivan Grunberger, M.D. Medical Director', 'organization': 'Brooklyn Urology Research Group'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Greenlight XPS Laser', 'description': 'Greenlight XPS Laser of the prostate\n\nGreenlight XPS Laser: Treatment of BPH with Greenlight XPS laser', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 2, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BiVAP Saline Vaporization', 'description': 'BiVAP Saline Vaporization of the prostate\n\nBiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 4, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'urethral stricture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in American Urological Association Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Greenlight XPS Laser', 'description': 'Greenlight XPS Laser of the prostate\n\nGreenlight XPS Laser: Treatment of BPH with Greenlight XPS laser'}, {'id': 'OG001', 'title': 'BiVAP Saline Vaporization', 'description': 'BiVAP Saline Vaporization of the prostate\n\nBiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.7', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '8.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The American Urological Association Symptom Score range is 0-35 with 35 being the most severe urinary symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All people who completed the study and had data available'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Greenlight XPS Laser', 'description': 'Greenlight XPS Laser of the prostate\n\nGreenlight XPS Laser: Treatment of BPH with Greenlight XPS laser'}, {'id': 'OG001', 'title': 'BiVAP Saline Vaporization', 'description': 'BiVAP Saline Vaporization of the prostate\n\nBiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '8.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 months', 'description': 'maximum urinary flow rate was measures using uroflow device', 'unitOfMeasure': 'ml/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed the study and have available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12 Months in Post Void Residual Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Greenlight XPS Laser', 'description': 'Greenlight XPS Laser of the prostate\n\nGreenlight XPS Laser: Treatment of BPH with Greenlight XPS laser'}, {'id': 'OG001', 'title': 'BiVAP Saline Vaporization', 'description': 'BiVAP Saline Vaporization of the prostate\n\nBiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization'}], 'classes': [{'categories': [{'measurements': [{'value': '-61.9', 'spread': '104.0', 'groupId': 'OG000'}, {'value': '-36.7', 'spread': '122.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 months', 'description': 'post void residual was measured using a bladder scan device', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed the study and have available data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Greenlight XPS Laser', 'description': 'Greenlight XPS Laser of the prostate\n\nGreenlight XPS Laser: Treatment of BPH with Greenlight XPS laser'}, {'id': 'FG001', 'title': 'BiVAP Saline Vaporization', 'description': 'BiVAP Saline Vaporization of the prostate\n\nBiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Greenlight XPS Laser', 'description': 'Greenlight XPS Laser of the prostate\n\nGreenlight XPS Laser: Treatment of BPH with Greenlight XPS laser'}, {'id': 'BG001', 'title': 'BiVAP Saline Vaporization', 'description': 'BiVAP Saline Vaporization of the prostate\n\nBiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.5', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '65.5', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '67.4', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-13', 'studyFirstSubmitDate': '2011-12-16', 'resultsFirstSubmitDate': '2018-04-13', 'studyFirstSubmitQcDate': '2011-12-23', 'lastUpdatePostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-13', 'studyFirstPostDateStruct': {'date': '2011-12-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in American Urological Association Symptom Score', 'timeFrame': 'Baseline and 12 months', 'description': 'The American Urological Association Symptom Score range is 0-35 with 35 being the most severe urinary symptoms'}, {'measure': 'Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax)', 'timeFrame': 'baseline and 12 months', 'description': 'maximum urinary flow rate was measures using uroflow device'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to 12 Months in Post Void Residual Volume', 'timeFrame': 'baseline and 12 months', 'description': 'post void residual was measured using a bladder scan device'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['enlarged prostate'], 'conditions': ['Benign Prostatic Hyperplasia (BPH)']}, 'descriptionModule': {'briefSummary': 'This is a Phase 4, prospective, open-label, randomized study of Greenlight XPS Laser versus BiVAP Saline Vaporization of the prostate in men with symptomatic Benign Prostatic Hyperplasia (BPH). The study consists of a screening phase, treatment, followed by follow-up visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male over the age of 18 years\n* present with symptomatic/ obstructive symptoms secondary to PBH requiring surgical intervention\n* subjects must read, understand and sign the Informed Consent\n* AUA ≥ 15\n* Qmax \\< 15mL/sec\n* Stopped BPH medication. Alpha blockers 15 days 5-α-reductase 3 months\n* Prostate volume ≥ 30g\n\nExclusion Criteria:\n\n* PVR \\> 300ml\n* Current urine retention\n* Previous surgical or invasive treatments (TURP, TUMT, TUNA)\n* PSA ≥ 4 (must have negative biopsy within last 12 months)\n* Neurogenic bladder\n* Obstruction due to urethral stricture\n* Any disorder or condition of the subject that the investigator believes will counter indicate their inclusion in the study'}, 'identificationModule': {'nctId': 'NCT01500057', 'briefTitle': 'Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia', 'organization': {'class': 'OTHER', 'fullName': 'Brooklyn Urology Research Group'}, 'officialTitle': 'An Open-Label Randomized Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia', 'orgStudyIdInfo': {'id': 'WIRB Protocol# 20111638'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Greenlight XPS Laser', 'description': 'Greenlight XPS Laser of the prostate', 'interventionNames': ['Device: Greenlight XPS Laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BiVAP Saline Vaporization', 'description': 'BiVAP Saline Vaporization of the prostate', 'interventionNames': ['Device: BiVAP Saline Vaporization of the prostate']}], 'interventions': [{'name': 'Greenlight XPS Laser', 'type': 'DEVICE', 'description': 'Treatment of BPH with Greenlight XPS laser', 'armGroupLabels': ['Greenlight XPS Laser']}, {'name': 'BiVAP Saline Vaporization of the prostate', 'type': 'DEVICE', 'description': 'treatment of BPH with BiVAP Saline Vaporization', 'armGroupLabels': ['BiVAP Saline Vaporization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11215', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Brooklyn Urology Research Group', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brooklyn Urology Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Medical Systems', 'class': 'INDUSTRY'}, {'name': 'Richard Wolf Medical Instruments Corporation (RWMIC)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Ivan Grunberger, MD', 'investigatorAffiliation': 'Brooklyn Urology Research Group'}}}}