Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-02-25 @ 2:41 AM
Study NCT ID:
NCT03123250
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2017-04-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}], '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'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098944', 'term': 'Aquablation'}], 'ancestors': [{'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D011468', 'term': 'Prostatectomy'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a.lee@procept-biorobotics.com', 'phone': '650-232-7215', 'title': 'Angela Lee', 'organization': 'PROCEPT BioRobotics Corporation'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The main limitation is that the trial is a single-arm study with a pre-specified performance goal and not randomized against another treatment arm.'}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Aquablation Procedure', 'description': 'Aquablation: To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 82, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 8}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ejaculatory dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 23}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 16}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multi-system organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scrotal edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aquablation Procedure', 'description': 'Aquablation: To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months post-treatment', 'description': 'The percentage of subjects with adverse events rated as probably or definitely related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (e.g. ejaculatory disorder or erectile dysfunction) evidenced through 3 months post treatment.', 'unitOfMeasure': 'percentage', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Total International Prostate Symptom Score (IPSS) Score at 3 Months as Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aquablation Procedure', 'description': 'Aquablation: To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.5', 'groupId': 'OG000', 'lowerLimit': '-18.1', 'upperLimit': '-14.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months post-treatment', 'description': 'The change in total IPSS score at 3 months as compared to baseline.\n\nThe objective of the International Prostate Symptom Score (IPSS) is to capture the severity of urinary symptoms related to benign prostatic hyperplasia IPSS ranges from 0 to 35. A higher score indicates a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed for this outcome measure consist of the participants who completed the IPSS questionnaire at 3 months post-treatment.'}, {'type': 'POST_HOC', 'title': 'Change in Total International Prostate Symptom Score (IPSS) Score at 60 Months as Compared to Baseline', 'timeFrame': '60 months post-treatment', 'description': 'The change in total IPSS score at 60 months as compared to baseline\n\nThe objective of the International Prostate Symptom Score (IPSS) is to capture the severity of urinary symptoms related to benign prostatic hyperplasia IPSS ranges from 0 to 35. A higher score indicates a worse outcome.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2023-07'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aquablation Procedure', 'description': 'Aquablation: To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.'}], 'periods': [{'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '1 Month Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '3 Months Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '2 subjects exited the study since the previous follow-up.', 'groupId': 'FG000', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '6 Months Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Since the previous follow-up, 1 subject who had exited the study was re-enrolled prior to the 6 months follow-up.', 'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '12 Months Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '4 subjects exited the study since the previous follow-up.', 'groupId': 'FG000', 'numSubjects': '96'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '24 Months Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Since the previous follow-up, 10 subjects did not reconsent to additional long-term follow-ups.', 'groupId': 'FG000', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '36 Months Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '4 subjects exited the study since the previous follow-up.', 'groupId': 'FG000', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '48 Months Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Since the previous follow-up, 16 subjects did not reconsent to additional long-term follow-ups.', 'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '60 Months Follow Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '4 subjects exited the study since the previous follow-up.', 'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Aquablation Procedure', 'description': 'Aquablation: To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'spread': '6.6', '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': '101', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '92', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Black', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '88', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '28.4', 'spread': '4.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Prostate size (TRUS)', 'classes': [{'categories': [{'measurements': [{'value': '107.4', 'spread': '22.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Prostate size as measured through transrectal ultrasound (TRUS).', 'unitOfMeasure': 'cc', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'International Prostate Symptom Score (IPSS)', 'classes': [{'categories': [{'measurements': [{'value': '23.2', 'spread': '6.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The objective of the International Prostate Symptom Score (IPSS) is to capture the severity of urinary symptoms related to benign prostatic hyperplasia\n\nIPSS ranges from 0 to 35. A higher score indicates a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-22', 'size': 1053462, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-12T19:28', 'hasProtocol': True}, {'date': '2018-01-09', 'size': 951885, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-12T19:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-02', 'studyFirstSubmitDate': '2017-04-11', 'resultsFirstSubmitDate': '2021-09-23', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-02', 'studyFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment', 'timeFrame': '3 months post-treatment', 'description': 'The percentage of subjects with adverse events rated as probably or definitely related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (e.g. ejaculatory disorder or erectile dysfunction) evidenced through 3 months post treatment.'}, {'measure': 'Change in Total International Prostate Symptom Score (IPSS) Score at 3 Months as Compared to Baseline', 'timeFrame': '3 months post-treatment', 'description': 'The change in total IPSS score at 3 months as compared to baseline.\n\nThe objective of the International Prostate Symptom Score (IPSS) is to capture the severity of urinary symptoms related to benign prostatic hyperplasia IPSS ranges from 0 to 35. A higher score indicates a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Lower Urinary Tract Symptoms (LUTS)', 'AQUABEAM', 'Aquablation', 'Benign Prostatic Hyperplasia (BPH)'], 'conditions': ['Benign Prostatic Hyperplasia (BPH)']}, 'referencesModule': {'references': [{'pmid': '37115632', 'type': 'BACKGROUND', 'citation': 'Bhojani N, Bidair M, Kramolowsky E, Desai M, Doumanian L, Zorn KC, Elterman D, Kaufman RP Jr, Eure G, Badlani G, Plante M, Uchio E, Gin G, Paterson R, So A, Roehrborn C, Motola J, Kaplan S, Humphreys M. Aquablation Therapy in Large Prostates (80-150 mL) for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: Final WATER II 5-Year Clinical Trial Results. J Urol. 2023 Jul;210(1):143-153. doi: 10.1097/JU.0000000000003483. Epub 2023 Apr 28.'}, {'pmid': '30734990', 'type': 'BACKGROUND', 'citation': 'Desai M, Bidair M, Zorn KC, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP Jr, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys M, Roehrborn C, Kaplan S, Motola J, Bhojani N. Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial. BJU Int. 2019 Aug;124(2):321-328. doi: 10.1111/bju.14703. Epub 2019 Mar 29.'}, {'pmid': '32333733', 'type': 'BACKGROUND', 'citation': 'Desai M, Bidair M, Bhojani N, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP Jr, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys MR, Roehrborn CG, Kaplan S, Motola J, Zorn KC. Aquablation for benign prostatic hyperplasia in large prostates (80-150 cc): 2-year results. Can J Urol. 2020 Apr;27(2):10147-10153.'}, {'pmid': '29694702', 'type': 'BACKGROUND', 'citation': 'Desai M, Bidair M, Bhojani N, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP Jr, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys M, Roehrborn C, Kaplan S, Motola J, Zorn KC. WATER II (80-150 mL) procedural outcomes. BJU Int. 2019 Jan;123(1):106-112. doi: 10.1111/bju.14360. Epub 2018 Jun 10.'}, {'pmid': '31059728', 'type': 'BACKGROUND', 'citation': 'Bhojani N, Bidair M, Zorn KC, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys M, Kaplan S, Motola J, Desai M, Roehrborn C. Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 cc): 1-Year Results. Urology. 2019 Jul;129:1-7. doi: 10.1016/j.urology.2019.04.029. Epub 2019 May 3.'}, {'pmid': '29873008', 'type': 'DERIVED', 'citation': 'Chughtai B, Thomas D. Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60-150 cc). Adv Ther. 2018 Jun;35(6):832-838. doi: 10.1007/s12325-018-0722-0. Epub 2018 Jun 5.'}]}, 'descriptionModule': {'briefSummary': 'Single-arm, interventional pivotal clinical trial collecting patient data from use of the AQUABEAM System, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH) with prostate volumes between 80 mL and 150 mL. The primary endpoints for safety and effectiveness will be measured at 3 months post-treatment. Treated subjects will be followed out to 60 months to collect long-term clinical data.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male age 45-80 years.\n* Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.\n* Subject has an IPSS score greater than or equal to 12.\n* Maximum urinary flow rate (Qmax) less than 15mL/s.\n* Serum creatinine \\< 2 mg/dL within 30 days of surgery.\n* History of inadequate or failed response, contraindication, or refusal to medical therapy.\n* Prostate size ≥ 80 mL and ≤ 150 mL as measured by TRUS.\n* Patient is mentally capable and willing to sign a study-specific informed consent form.\n\nExclusion Criteria:\n\n* BMI ≥ 42.\n* Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care.\n* Participants using systemic immune-suppressants including corticosteroids (except inhalants); unable to withhold non-steroidal anti-inflammatory agents (NSAIDs, including aspirin) prior to treatment per standard or care except for low dose aspirin (e.g. less than or equal to 100mg).\n* Contraindication to both general and spinal anesthesia.\n* Any severe illness that would prevent complete study participation or confound study results.\n* History of prostate cancer or current/suspected bladder cancer. Prostate cancer should be ruled out before participation to the satisfaction of the investigator if PSA is above acceptable thresholds.\n* History of actively treated bladder cancer within the past two (2) years.\n* Clinically significant bladder calculus or bladder diverticulum (e.g., pouch size \\>20% of full bladder size).\n* Active infection, including urinary tract infection or prostatitis.\n* Urinary catheter use daily for 90 or more days consecutively.\n* Previous urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis.\n* Ever been diagnosed with a clinically significant urethral stricture or meatal stenosis, or bladder neck contracture.\n* Known damage to external urinary sphincter.\n* Has had an open heart surgery, or cardiac arrest \\< 180 days prior to the date of informed consent.\n* Participants using anticholinergics specifically for bladder problems. Use of medications with anticholinergic properties is allowable provided the patient does not have documented adverse urinary side effects from these medications.\n* Subject is unwilling to accept a transfusion should one be required.'}, 'identificationModule': {'nctId': 'NCT03123250', 'acronym': 'WATERII', 'briefTitle': 'Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II', 'organization': {'class': 'INDUSTRY', 'fullName': 'PROCEPT BioRobotics'}, 'officialTitle': 'Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II', 'orgStudyIdInfo': {'id': 'TP0124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aquablation procedure', 'interventionNames': ['Device: Aquablation']}], 'interventions': [{'name': 'Aquablation', 'type': 'DEVICE', 'description': 'The procedure is performed with the AquaBeam System. It is designed to utilize a high-velocity sterile saline waterjet as the cutting medium, which is projected through a nozzle positioned within the prostatic urethra. The Aquablation procedure integrates real-time ultrasound imaging with a robotically executed surgeon guided high-velocity waterjet to resect prostate tissue.', 'armGroupLabels': ['Aquablation procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Tibor Rubin VA Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California, Institute of Urology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Clinical Trials', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Adult & Pediatrics Urology', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical College', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '75390-9110', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '05054', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Urology', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23462', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Urology of Virginia', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M5G 1Z6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Toronto-University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Université de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PROCEPT BioRobotics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}