Trials / Completed
CompletedNCT02505919
Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER)
A Prospective Multicenter Randomized Blinded Study Comparing Aquablation of the Prostate With the AQUABEAM System and TURP for the Treatment of LUTS
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 184 (actual)
- Sponsor
- PROCEPT BioRobotics · Industry
- Sex
- Male
- Age
- 45 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
A prospective multicenter randomized blinded study comparing Aquablation of the prostate with the AQUABEAM System and TURP for the treatment of Lower Urinary Tract Symptoms (LUTS). The primary endpoints for safety and effectiveness were measured at 3 and 6 months, respectively, and subjects were followed out to 5 years to collect long-term clinical data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AQUABEAM System | The AQUABEAM system, a personalized image-guided tissue removal system, utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue. |
| PROCEDURE | Transurethral Resection of the Prostate (TURP) | Transurethral resection of the prostate (TURP) is a type of prostate surgery done to relieve moderate to severe urinary symptoms caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH) |
Timeline
- Start date
- 2015-10-30
- Primary completion
- 2017-07-14
- Completion
- 2021-12-16
- First posted
- 2015-07-22
- Last updated
- 2023-07-03
- Results posted
- 2020-04-08
Locations
17 sites across 4 countries: United States, Australia, New Zealand, United Kingdom
Source: ClinicalTrials.gov record NCT02505919. Inclusion in this directory is not an endorsement.