Prince of Wales Hospital
Shatin, Hong Kong
Not Yet Recruiting
NCT Number: NCT07728071
Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
Prospective, single-arm, single-site, post-market device study; all procedures use Veloxion™ per IFU.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
30 year–70 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Uncorrectable coagulopathy; inability to manage antithrombotics.
- Severe medical comorbidity precluding anesthesia or endoscopy.
Treatment and study plan
TURP using the Aulea Veloxion™ Disposable Resectoscope System
ProcedureTURP 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.
Primary outcomes
-
Difference in total procedure time versus a pre-specified benchmark
Time frame: Perioperative
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
Time frame: Perioperative
Derived from historical standard reusable resectoscope TURP/TURP-like procedures at the same site, tested against a superiority margin
Secondary outcomes
-
Total Resection time
Time frame: Intra-operative
The cumulative electrosurgery activation time (minutes) from generator logs and video annotation.
-
The Instrument exchanges time
Time frame: Intra-operative
The count and cumulative time with scope out-of-field; standardized categories (loop, electrode, sheath, camera).
-
The Visibility score
Time frame: Intra-operative
Assessed by the surgeon-rated 5-point Likert per 15-minute epoch; total irrigation volume; number of bag exchanges; "red-out" events.
-
Adverse event
Time frame: Within post-operative 30 days
By "Clavien-Dindo Classification"
-
The cost per case
Time frame: Intra-operative
equipment, facility, consumables, device, reprocessing, repair, maintenance, rental (if applicable), staff cost to perform the surgery
-
Staff usability scores
Time frame: Intra-operative
By OR nurse and scrub tech 5-point Likert for setup ease, troubleshooting, case flow.
-
Total procedure time
Time frame: intra-operative
The time from scope insertion to final scope removal (minutes) from OR time logs/video time stamps.
Study contacts
Contact information is provided by the study sponsor or research team.
Alex Qinyang LIU, MBBS, MSc, FRCSEd
CONTACT
Chi Fai NG, MBChB, MD, FRCSEd
CONTACT
Sponsors and collaborators
Lead sponsor
Chinese University of Hong Kong
Other
Registry information
Official study title
Prospective, Single-Site, Single-Arm Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jul 27, 2026
- Registry last updated
- Jul 27, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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