BPH (Benign Prostatic Hyperplasia)
Conditions
Keywords
Surgical management of BPH
Brief summary
Prospective, single-arm, single-site, post-market device study; all procedures use Veloxion™ per IFU.
Detailed description
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).
Interventions
PROCEDURETURP using the 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.
DEVICEAulea Veloxion™ Disposable Resectoscope System
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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in total procedure time versus a pre-specified benchmark | 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 | Perioperative | Derived from historical standard reusable resectoscope TURP/TURP-like procedures at the same site, tested against a superiority margin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Resection time | Intra-operative | The cumulative electrosurgery activation time (minutes) from generator logs and video annotation. |
| The Instrument exchanges time | Intra-operative | The count and cumulative time with scope out-of-field; standardized categories (loop, electrode, sheath, camera). |
| The Visibility score | 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 | Within post-operative 30 days | By "Clavien-Dindo Classification" |
| The cost per case | Intra-operative | equipment, facility, consumables, device, reprocessing, repair, maintenance, rental (if applicable), staff cost to perform the surgery |
| Staff usability scores | Intra-operative | By OR nurse and scrub tech 5-point Likert for setup ease, troubleshooting, case flow. |
| Total procedure time | intra-operative | The time from scope insertion to final scope removal (minutes) from OR time logs/video time stamps. |
Countries
Hong Kong
Contacts
CONTACTAlex Qinyang LIU, MBBS, MSc, FRCSEd
CONTACTChi Fai NG, MBChB, MD, FRCSEd
PRINCIPAL_INVESTIGATORQinyang LIU, MBBS, MSc, FRCSEd
Chinese University of Hong Kong
Outcome results
None listed