N/A
N=101
Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II
Benign Prostatic Hyperplasia (BPH)
Bottom Line
View on ClinicalTrials.gov: NCT03123250 ↗Enrolled (actual)
101
Serious AEs
17.8%
Results posted
Jun 2023
Primary outcome: Primary: Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment — 45.5 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aquablation (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- PROCEPT BioRobotics
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment |
45.5 | — |
| PRIMARY Change in Total International Prostate Symptom Score (IPSS) Score at 3 Months as Compared to Baseline |
-16.5 | — |
Summary
Single-arm, interventional pivotal clinical trial collecting patient data from use of the AQUABEAM System, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH) with prostate volumes between 80 mL and 150 mL. The primary endpoints for safety and effectiveness will be measured at 3 months post-treatment. Treated subjects will be followed out to 60 months to collect long-term clinical data.
Eligibility Criteria
Inclusion Criteria
- Male age 45-80 years.
- Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
- Subject has an IPSS score greater than or equal to 12.
- Maximum urinary flow rate (Qmax) less than 15mL/s.
- Serum creatinine 20% of full bladder size).
- Active infection, including urinary tract infection or prostatitis.
- Urinary catheter use daily for 90 or more days consecutively.
- Previous urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis.
- Ever been diagnosed with a clinically significant urethral stricture or meatal stenosis, or bladder neck contracture.
- Known damage to external urinary sphincter.
- Has had an open heart surgery, or cardiac arrest < 180 days prior to the date of informed consent.
- Participants using anticholinergics specifically for bladder problems. Use of medications with anticholinergic properties is allowable provided the patient does not have documented adverse urinary side effects from these medications.
- Subject is unwilling to accept a transfusion should one be required.
Data sourced from ClinicalTrials.gov (NCT03123250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.