An interventional study of TURP using the Aulea Veloxion™ Disposable Resectoscope System and Aulea Veloxion™ Disposable Resectoscope System in BPH (Benign Prostatic Hyperplasia), sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to male participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
Prospective, single-arm, single-site, post-market device study; all procedures use Veloxion™ per IFU.
The aim of the study is to prospectively evaluate the operational efficiency and safety of the Veloxion™ disposable resectoscope system when used for endoscopic surgical treatment of benign prostatic hyperplasia. Subjects will be followed up on 2 weeks (phone/clinic) and 1 month, (phone/clinic, safety assessments, device-related AEs, reinterventions, usability feedback).
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 20 is below the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Procedure: TURP using the Aulea Veloxion™ Disposable Resectoscope System · Device: Aulea Veloxion™ Disposable Resectoscope System
TURP 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.
Veloxion™ 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
Time frame: Perioperative
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
Time frame: Perioperative
Total Resection time
The cumulative electrosurgery activation time (minutes) from generator logs and video annotation.
Time frame: Intra-operative
The Instrument exchanges time
The count and cumulative time with scope out-of-field; standardized categories (loop, electrode, sheath, camera).
Time frame: Intra-operative
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.
Time frame: Intra-operative
Adverse event
By "Clavien-Dindo Classification"
Time frame: Within post-operative 30 days
The cost per case
equipment, facility, consumables, device, reprocessing, repair, maintenance, rental (if applicable), staff cost to perform the surgery
Time frame: Intra-operative
Staff usability scores
By OR nurse and scrub tech 5-point Likert for setup ease, troubleshooting, case flow.
Time frame: Intra-operative
Total procedure time
The time from scope insertion to final scope removal (minutes) from OR time logs/video time stamps.
Time frame: intra-operative
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Jun 2027, 8 months after the start.
Of 152 non-industry interventional studies with no phase under Prostatic Hyperplasia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 8 months is below that.
Counting every sponsor, half of 203 studies reached it within 26 months; a quarter within 14 and three quarters within 48.
Start moved once since we started tracking on Sep 25, 2026: Jul 2026 → Oct 2026, on Oct 27, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Chinese University of Hong Kong →