Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-03-08 @ 12:25 AM
Study NCT ID:
NCT04658056
Status:
UNKNOWN
Last Update Posted:
2020-12-08
First Post:
2020-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UK Post-market Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-14', 'releaseDate': '2023-08-21'}], 'estimatedResultsFirstSubmitDate': '2023-08-21'}}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-01', 'studyFirstSubmitDate': '2020-12-01', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reoperation or Re-intervention at 60 months', 'timeFrame': '60 months', 'description': 'Reoperation or Re-intervention at 60 months'}, {'measure': 'IPSS-QoL at 60 months', 'timeFrame': '60 months', 'description': 'International Prostate Symptom Score Quality of Life sub-score'}, {'measure': 'Qmax at 60 months', 'timeFrame': '60 months', 'description': 'Uroflowmetry measurement of voided urine (in milliliters) per unit of time (in seconds)'}, {'measure': 'PVR at 60 months', 'timeFrame': '60 months', 'description': 'Post-void residual urine test'}, {'measure': 'Erectile function at 60 months', 'timeFrame': '60 months', 'description': 'IIEF-15 score'}, {'measure': 'MSHQ-EjD at 60 months', 'timeFrame': '60 months', 'description': 'Assessment of ejaculatory function/dysfunction'}], 'primaryOutcomes': [{'measure': 'Long-term effectiveness as measured by IPSS at 60 months', 'timeFrame': '60 months following original surgical intervention', 'description': 'International Prostate Symptom Score at 60 months as compared to baseline'}, {'measure': 'Long-term safety as measured by adverse events at 60 months', 'timeFrame': '60 months following original surgical intervention', 'description': 'The proportion of subjects with adverse events classified as Clavien-Dindo Grade 2 or higher or any grade 1 event resulting in persistent disability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Benign Prostatic Hyperplasia', 'Lower Urinary Tract Symptoms']}, 'referencesModule': {'references': [{'pmid': '32065861', 'type': 'RESULT', 'citation': 'Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Plante M, Desai M, Doumanian L, Te AE, DeGuenther M, Roehrborn C. Three-year outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial. Can J Urol. 2020 Feb;27(1):10072-10079.'}, {'pmid': '31028614', 'type': 'RESULT', 'citation': 'Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Plante M, Desai M, Doumanian L, Te AE, DeGuenther M, Roehrborn C. Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained. Adv Ther. 2019 Jun;36(6):1326-1336. doi: 10.1007/s12325-019-00952-3. Epub 2019 Apr 26.'}, {'pmid': '30721737', 'type': 'RESULT', 'citation': 'Pimentel MA, Yassaie O, Gilling P. Urodynamic Outcomes After Aquablation. Urology. 2019 Apr;126:165-170. doi: 10.1016/j.urology.2019.01.020. Epub 2019 Feb 2.'}, {'pmid': '30552937', 'type': 'RESULT', 'citation': 'Gilling PJ, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Roehrborn C. Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes. Urology. 2019 Mar;125:169-173. doi: 10.1016/j.urology.2018.12.002. Epub 2018 Dec 12.'}, {'pmid': '29873008', 'type': 'RESULT', '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': 'A post-market, non-interventional, two-arm, long-term follow-up study of patients previously enrolled in the WATER Study (NCT02505919) - which was a prospective multi-centre randomized blinded study comparing Aquablation of the prostate with the AQUABEAM Robotic System with standard transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS).', 'detailedDescription': 'The study is a post-market, non-interventional, two-arm, long-term follow-up study of patients previously enrolled in the WATER Study (NCT02505919) - which was a prospective multi-centre randomized blinded study comparing Aquablation of the prostate with the AQUABEAM Robotic System with standard transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS). In POST WATER, up to 46 WATER Study subjects in the United Kingdom who were active on the study at 36 months will be invited to participate, across 3 clinical study sites in England and Wales. The study will consist of one follow-up time-point at 60 months (5 years) from the time of initial WATER Study treatment date.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The target patient population is subjects who were enrolled in the WATER Study (with symptomatic BPH) who were randomized to treatment with either the Aquablation procedure or TURP.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject was randomized and received treatment in the WATER Study.\n2. Subject is mentally capable and willing to sign a study-specific informed consent form\n3. Subject is willing and able to comply with all study requirements\n\nExclusion Criteria:\n\nDementia or psychiatric condition that prevents the participant from completing required follow up 2. Participating in another investigational study that could affect responses to the study assessments'}, 'identificationModule': {'nctId': 'NCT04658056', 'briefTitle': 'UK Post-market Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue', 'organization': {'class': 'INDUSTRY', 'fullName': 'PROCEPT BioRobotics'}, 'officialTitle': 'The UK POST WATERStudy: UK Post-market Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue', 'orgStudyIdInfo': {'id': 'CSP0002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'WATER AQUABEAM Robotic System cohort', 'description': 'WATER Study subjects previously-treated with Aquablation of the prostate with the AQUABEAM Robotic System for lower urinary tract symptoms associated with BPH.'}, {'label': 'WATER TURPS cohort', 'description': 'WATER Study subjects previously-treated with standard transurethral resection of the prostate (TURP) for lower urinary tract symptoms associated with BPH.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GU16 7UJ', 'city': 'Camberley', 'state': 'Surrey', 'country': 'United Kingdom', 'contacts': [{'name': 'Alexandra Edwards, RN', 'role': 'CONTACT', 'email': 'alexandra.edwards3@nhs.net'}, {'name': 'Neil Barber, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Frimley Park Hospital', 'geoPoint': {'lat': 51.33705, 'lon': -0.74261}}], 'centralContacts': [{'name': 'Angela Lee', 'role': 'CONTACT', 'email': 'a.lee@procept-biorobotics.com', 'phone': '+46 738417897'}], 'overallOfficials': [{'name': 'Claus Roehrborn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Southwestern Medical'}, {'name': 'Peter Gilling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tauranga Urology Research Limited'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PROCEPT BioRobotics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-08-21', 'type': 'RELEASE'}, {'date': '2024-03-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'PROCEPT BioRobotics'}}}}