Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
- Conditions
- BPH
- Registration Number
- NCT02974751
- Lead Sponsor
- PROCEPT BioRobotics
- Brief Summary
The purpose of this study is to evaluate the efficacy of the AQUABEAM System for the treatment of Lower Urinary Tract Symptoms (LUTS) resulting from Benign Prostatic Hyperplasia (BPH).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 178
Inclusion Criteria
- Male.
- Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction or in urinary retention.
- Prostate size ≥ 20 mL and ≤ 150 mL as measure by TRUS.
- Patient is mentally capable and willing to sign a study-specific informed consent form.
Exclusion Criteria
- Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care.
- History of gross haematuria.
- Participants using systemic immune-suppressants including corticosteroids (except inhalants), known coagulopathy, or platelet disorder (except aspirin below 100mg/d).
- Contraindication to both general and spinal anesthesia.
- Any severe illness that would prevent complete study participation or confound study results.
- Subject is unwilling to accept a transfusion should one be required.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method IPSS score change 3 months
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which waterjet ablation improves LUTS in BPH patients?
How does the AQUABEAM System compare to transurethral resection of the prostate (TURP) in treating BPH symptoms?
Are there specific biomarkers that identify BPH patients most likely to benefit from waterjet ablation therapy?
What adverse events are associated with waterjet ablation for BPH and how are they managed clinically?
What are the current trends in minimally invasive BPH treatments compared to traditional surgical approaches?
Trial Locations
- Locations (5)
Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia
Asklepios Klinikum Harburg
🇩🇪Hamburg, Germany
American University of Beirut Medical Center
🇱🇧Beirut, Lebanon
Tauranga Urology Research
🇳🇿Tauranga, New Zealand
Frimley Park Hospital
🇬🇧Frimley, Surrey, United Kingdom
Royal Melbourne Hospital🇦🇺Melbourne, Victoria, Australia