Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-03-10 @ 8:36 PM
Study NCT ID:
NCT02974751
Status:
UNKNOWN
Last Update Posted:
2019-10-22
First Post:
2016-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-02-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-18', 'studyFirstSubmitDate': '2016-11-23', 'studyFirstSubmitQcDate': '2016-11-23', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IPSS score change', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aquablation', 'AQUABEAM', 'BPH', 'LUTS'], 'conditions': ['BPH']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of the AQUABEAM System for the treatment of Lower Urinary Tract Symptoms (LUTS) resulting from Benign Prostatic Hyperplasia (BPH).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with lower urinary tract symptoms, including those with urinary retention, who meet all other enrollment criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male.\n* Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction or in urinary retention.\n* Prostate size ≥ 20 mL and ≤ 150 mL as measure by TRUS.\n* Patient is mentally capable and willing to sign a study-specific informed consent form.\n\nExclusion Criteria:\n\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* History of gross haematuria.\n* Participants using systemic immune-suppressants including corticosteroids (except inhalants), known coagulopathy, or platelet disorder (except aspirin below 100mg/d).\n* Contraindication to both general and spinal anesthesia.\n* Any severe illness that would prevent complete study participation or confound study results.\n* Subject is unwilling to accept a transfusion should one be required.'}, 'identificationModule': {'nctId': 'NCT02974751', 'acronym': 'OPEN WATER', 'briefTitle': 'Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue', 'organization': {'class': 'INDUSTRY', 'fullName': 'PROCEPT BioRobotics'}, 'officialTitle': 'Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue', 'orgStudyIdInfo': {'id': 'TP0118'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Aquablation', 'type': 'PROCEDURE', 'description': 'Aquablation is a minimally invasive transurethral surgical procedure using the AQUABEAM system, a personalized image-guided waterject resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '21075', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Klinikum Harburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Beirut', 'country': 'Lebanon', 'facility': 'American University of Beirut Medical Center', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'zip': '3112', 'city': 'Tauranga', 'country': 'New Zealand', 'facility': 'Tauranga Urology Research', 'geoPoint': {'lat': -37.68611, 'lon': 176.16667}}, {'zip': 'GU16 7UJ', 'city': 'Frimley', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Frimley Park Hospital', 'geoPoint': {'lat': 51.31667, 'lon': -0.74544}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PROCEPT BioRobotics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}