Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-31 @ 2:44 AM
Study NCT ID:
NCT05169892
Status:
RECRUITING
Last Update Posted:
2021-12-27
First Post:
2021-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aquablation in Benign Prostatic Hyperplasia in Canada
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014570', 'term': 'Urologic Diseases'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-09', 'studyFirstSubmitDate': '2021-11-27', 'studyFirstSubmitQcDate': '2021-12-09', 'lastUpdatePostDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum flow rate (Q-max)', 'timeFrame': 'Baseline', 'description': 'Standard of care'}, {'measure': 'Post-Void Residual (PVR) volume', 'timeFrame': 'Baseline', 'description': 'Standard of care'}, {'measure': 'Maximum flow rate (Q-max)', 'timeFrame': '1 month after surgery', 'description': 'Standard of care'}, {'measure': 'Post-Void Residual (PVR) volume', 'timeFrame': '1 month after surgery', 'description': 'Standard of care'}, {'measure': 'Maximum flow rate (Q-max)', 'timeFrame': '3 months after surgery', 'description': 'Standard of care'}, {'measure': 'Post-Void Residual (PVR) volume', 'timeFrame': '3 months after surgery', 'description': 'Standard of care'}, {'measure': 'Maximum flow rate (Q-max)', 'timeFrame': '6 months after surgery', 'description': 'Standard of care'}, {'measure': 'Post-Void Residual (PVR) volume', 'timeFrame': '6 months after surgery', 'description': 'Standard of care'}, {'measure': 'Maximum flow rate (Q-max)', 'timeFrame': '12 months after surgery', 'description': 'Standard of care'}, {'measure': 'Post-Void Residual (PVR) volume', 'timeFrame': '12 months after surgery', 'description': 'Standard of care'}, {'measure': 'Maximum flow rate (Q-max)', 'timeFrame': '24 months after surgery', 'description': 'Standard of care'}, {'measure': 'Post-Void Residual (PVR) volume', 'timeFrame': '24 months after surgery', 'description': 'Standard of care'}, {'measure': 'Maximum flow rate (Q-max)', 'timeFrame': '36 months after surgery', 'description': 'Standard of care'}, {'measure': 'Post-Void Residual (PVR) volume', 'timeFrame': '36 months after surgery', 'description': 'Standard of care'}, {'measure': 'Prostate Volume', 'timeFrame': 'Baseline', 'description': 'Standard of care'}, {'measure': 'Prostate Volume', 'timeFrame': '12 months after surgery', 'description': 'Standard of care'}, {'measure': 'Questionnaires', 'timeFrame': 'Baseline', 'description': 'IPSS'}, {'measure': 'Questionnaires', 'timeFrame': '1 month after surgery', 'description': 'IPSS'}, {'measure': 'Questionnaires', 'timeFrame': '3 months after surgery', 'description': 'IPSS'}, {'measure': 'Questionnaires', 'timeFrame': '6 months after surgery', 'description': 'IPSS'}, {'measure': 'Questionnaires', 'timeFrame': '12 months after surgery', 'description': 'IPSS'}, {'measure': 'Questionnaires', 'timeFrame': '24 months after surgery', 'description': 'IPSS'}, {'measure': 'Questionnaires', 'timeFrame': '36 months after surgery', 'description': 'IPSS'}, {'measure': 'Adverse Events', 'timeFrame': 'Baseline', 'description': 'Adverse Events'}, {'measure': 'Adverse Events', 'timeFrame': '1 day of Surgery', 'description': 'Adverse Events'}, {'measure': 'Adverse Events', 'timeFrame': '1 month after surgery', 'description': 'Adverse Events'}, {'measure': 'Adverse Events', 'timeFrame': '3 months after surgery', 'description': 'Adverse Events'}, {'measure': 'Adverse Events', 'timeFrame': '6 months after surgery', 'description': 'Adverse Events'}, {'measure': 'Adverse Events', 'timeFrame': '12 months after surgery', 'description': 'Adverse Events'}, {'measure': 'Adverse Events', 'timeFrame': '24 months after surgery', 'description': 'Adverse Events'}, {'measure': 'Adverse Events', 'timeFrame': '36 months after surgery', 'description': 'Adverse Events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['benigh prostate hypertrophy'], 'conditions': ['Urologic Diseases']}, 'descriptionModule': {'briefSummary': 'To document the clinical outcome of Aquablation therapy for BPH patient in Canadian cohort.', 'detailedDescription': 'Patients will be followed up for 3 years as standard of care.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'BPH patients treated by Aquablation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of Benign Prostate Hypertrophy (BPH)\n* Male subjects of ≥ 18 years of age\n* Candidate for Aquablation therapy as per clinical decision of Investigator\n* Willing and able to accurately complete questionnaires\n* Willing and able to provide signed and dated informed consent\n\nExclusion Criteria:\n\n* Characteristics indicating a poor compliance with study protocol requirements.\n* Disease or other health condition that is not suitable for this study.\n* Unable or unwilling to provide signed informed consent.'}, 'identificationModule': {'nctId': 'NCT05169892', 'briefTitle': 'Aquablation in Benign Prostatic Hyperplasia in Canada', 'organization': {'class': 'OTHER', 'fullName': 'Can-Am HIFU Inc.'}, 'officialTitle': 'Canadian Cohort of Aquablation, a Robotically Executed, Surgeon-guided, High-pressure Water Jet Ablation Therapy for Endoscopic Resection of Prostate Tissue, in Benign Prostatic Hyperplasia (BPH).', 'orgStudyIdInfo': {'id': 'Aquablation in BPH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aquablation', 'interventionNames': ['Procedure: Aquablation']}], 'interventions': [{'name': 'Aquablation', 'type': 'PROCEDURE', 'description': 'Aquablation', 'armGroupLabels': ['Aquablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Dean Elterman', 'role': 'CONTACT', 'email': 'dean.elterman@uhn.ca', 'phone': '4166035800', 'phoneExt': '5033'}, {'name': 'Iris Chan', 'role': 'CONTACT', 'email': 'dean.elterman@uhn.ca', 'phone': '4166035800', 'phoneExt': 'Elterman'}, {'name': 'Dean Elterman', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dean Elterman', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Dean Elterman', 'role': 'CONTACT', 'email': 'dean.elterman@uhn.ca', 'phone': '4166035800', 'phoneExt': '5033'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Can-Am HIFU Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Urologist', 'investigatorFullName': 'Dean Elterman', 'investigatorAffiliation': 'Can-Am HIFU Inc.'}}}}