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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04658056




Registration number
NCT04658056
Ethics application status
Date submitted
1/12/2020
Date registered
8/12/2020
Date last updated
8/12/2020

Titles & IDs
Public title
UK Post-market Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
Scientific title
The UK POST WATERStudy: UK Post-market Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
Secondary ID [1] 0 0
CSP0002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 0 0
Lower Urinary Tract Symptoms 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
WATER AQUABEAM Robotic System cohort - WATER Study subjects previously-treated with Aquablation of the prostate with the AQUABEAM Robotic System for lower urinary tract symptoms associated with BPH.

WATER TURPS cohort - WATER Study subjects previously-treated with standard transurethral resection of the prostate (TURP) for lower urinary tract symptoms associated with BPH.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Long-term effectiveness as measured by IPSS at 60 months
Timepoint [1] 0 0
60 months following original surgical intervention
Primary outcome [2] 0 0
Long-term safety as measured by adverse events at 60 months
Timepoint [2] 0 0
60 months following original surgical intervention

Eligibility
Key inclusion criteria
1. Subject was randomized and received treatment in the WATER Study.
2. Subject is mentally capable and willing to sign a study-specific informed consent form
3. Subject is willing and able to comply with all study requirements
Minimum age
45 Years
Maximum age
85 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Dementia 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2022
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
PROCEPT BioRobotics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/study/NCT04658056
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Claus Roehrborn, MD
Address 0 0
UT Southwestern Medical
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Angela Lee
Address 0 0
Country 0 0
Phone 0 0
+46 738417897
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04658056