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Australia &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 will be measured at 3 and 6 months, respectively, and subjects will be followed out to 3 years to collect long-term clinical data.
| Condition | Intervention | Phase |
|---|---|---|
| Benign Prostatic Hyperplasia (BPH) | Device: Aquablation Procedure: Transurethral Resection of the Prostate (TURP) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Prospective Multicenter Randomized Blinded Study Comparing Aquablation of the Prostate With the AQUABEAM System and TURP for the Treatment of LUTS |
Resource links provided by NLM:
Further study details as provided by PROCEPT BioRobotics:
Primary Outcome Measures:
- Adverse Events Comparison for Safety [ Time Frame: Three months post-treatment ] [ Designated as safety issue: Yes ]
Three Month comparison between control and treatment arms of AEs
- IPSS Comparison for Efficacy [ Time Frame: Six months post-treatment ] [ Designated as safety issue: No ]
Six Month comparison between control and treatment arms of IPSS
| Estimated Enrollment: | 237 |
| Study Start Date: | September 2015 |
| Estimated Study Completion Date: | September 2019 |
| Estimated Primary Completion Date: | March 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment
Aquablation procedure
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Device: Aquablation
To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.
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| Active Comparator: Control
Transurethral Resection of the Prostate (TURP)
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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)
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Eligibility
| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
– Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction
Exclusion Criteria:
– Prostate size
This information was originally posted on www.clinicaltrials.gov.