Prospective, single-arm, single-site, post-market device study; all procedures use Veloxion™ per IFU.
Age 30-70 years old with symptomatic BPH.
Prostate volume 20-120 mL (TRUS/MRI/US)
Suitable for endoscopic resection/vaporization per device IFU.
Able to consent and comply with follow-up to 1 month.
Known/suspected prostate cancer requiring oncologic management.
Prior prostate surgery impacting urethral anatomy within 12 months.
Prior implant affecting urethral anatomy.
Active UTI or untreated bacteriuria pre-op.
Single group
TURP using the Aulea Veloxion™ Disposable Resectoscope System
Procedure/SurgeryTURP will be performed by Aulea Veloxion™ Disposable Resectoscope System. The resectoscopes are single-use and ensure consistent quality and no cross-contamination. The automated fluid management system continuously monitors and manages intravesical pressure while actively evacuating tissue to prevent clogging. The active power generation system optimize plasma generation for effective resection and extended equipment life. This system allows transurethral resection of prostate to be performed in a motorized and highly effective manner. This study is designed to prospectively characterize operational efficiency in real-world BPH resections using the cleared device platform.
Aulea Veloxion™ Disposable Resectoscope System
DeviceVeloxion™ platform disposable resectoscope is FDA-cleared for treatment of BPH. It is an all-in-one, platform that combines fluid control, video pipeline and energy generator. The resectoscopes are single-use and ensure consistent quality and no cross-contamination. The automated fluid management system continuously monitors and manages intravesical pressure while actively evacuating tissue to prevent clogging. The active power generation system optimize plasma generation for effective resection and extended equipment life. This system allows transurethral resection of prostate to be performed in a motorized and highly effective manner. This study is designed to prospectively characterize operational efficiency in real-world BPH resections using the cleared device platform.
Difference in total procedure time versus a pre-specified benchmark
Derived from historical standard reusable resectoscope TURP/TURP-like procedures at the same site, tested against a superiority margin
Difference in case cost versus a pre-specified benchmark
Derived from historical standard reusable resectoscope TURP/TURP-like procedures at the same site, tested against a superiority margin
Total Resection time
The cumulative electrosurgery activation time (minutes) from generator logs and video annotation.
The Instrument exchanges time
The count and cumulative time with scope out-of-field; standardized categories (loop, electrode, sheath, camera).
The Visibility score
Assessed by the surgeon-rated 5-point Likert per 15-minute epoch; total irrigation volume; number of bag exchanges; "red-out" events.
Adverse event
By "Clavien-Dindo Classification"
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