NCT04658056

UK Post-market Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

The UK POST WATERStudy: UK Post-market Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 46 (estimated)
• Sponsor: PROCEPT BioRobotics · Industry
• Sex: Male
• Age: 45 Years – 85 Years
• Healthy volunteers: —

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).

Detailed description

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.

Conditions

• Benign Prostatic Hyperplasia
• Lower Urinary Tract Symptoms

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-01-01
• Completion: 2022-02-01
• First posted: 2020-12-08
• Last updated: 2020-12-08

Locations

1 site across 1 country: United Kingdom