Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)

Prospective, Single-Site, Single-Arm 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.

Study Overview

• Status: Not yet recruiting
• Conditions: BPH (Benign Prostatic Hyperplasia)
• Intervention / Treatment: Procedure: TURP using the Aulea Veloxion™ Disposable Resectoscope System; Device: Aulea Veloxion™ Disposable Resectoscope System

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).

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex Qinyang LIU, MBBS, MSc, FRCSEd; Phone Number: +852-3505-2625; Email: alexliu@surgery.cuhk.edu.hk
• Study Contact Backup: Name: Chi Fai NG, MBChB, MD, FRCSEd; Phone Number: +852-3505-2625; Email: ngcf@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Prince of Wales Hospital
    • Contact: Qinyang LIU, MBBS, MSc, FRCSEd; Phone Number: +852-3505-2625; Email: alexliu@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Aulea Veloxion™ Disposable Resectoscope System

Procedure: TURP 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.; Device: Aulea 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Resection time	The cumulative electrosurgery activation time (minutes) from generator logs and video annotation.	Intra-operative
The Instrument exchanges time	The count and cumulative time with scope out-of-field; standardized categories (loop, electrode, sheath, camera).	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.	Intra-operative
Adverse event	By "Clavien-Dindo Classification"	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	Intra-operative
Staff usability scores	By OR nurse and scrub tech 5-point Likert for setup ease, troubleshooting, case flow.	Intra-operative
Total procedure time	The time from scope insertion to final scope removal (minutes) from OR time logs/video time stamps.	intra-operative

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Qinyang LIU, MBBS, MSc, FRCSEd, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): July 16, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Surgical management of BPH
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia
• Other Study ID Numbers: CRE-2026.117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes