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

NCT07728071 | Not Yet Recruiting FDA Device

• 1 other identifier: CRE-2026.117
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, single-arm, single-site, post-market device study; all procedures use Veloxion™ per IFU.

Conditions

BPH (Benign Prostatic Hyperplasia)

Keywords

Surgical management of BPH

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Total Resection time

  Intra-operative

• The Instrument exchanges time

  Intra-operative

• The Visibility score

  Intra-operative

• Adverse event

  Within post-operative 30 days

• The cost per case

  Intra-operative

Study Arms (1)

Aulea Veloxion™ Disposable Resectoscope System

EXPERIMENTAL

Procedure: TURP using the Aulea Veloxion™ Disposable Resectoscope System; Device: Aulea Veloxion™ Disposable Resectoscope System

Interventions

TURP using the Aulea Veloxion™ Disposable Resectoscope System PROCEDURE

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.

Aulea Veloxion™ Disposable Resectoscope System

Aulea Veloxion™ Disposable Resectoscope System DEVICE

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.

Aulea Veloxion™ Disposable Resectoscope System

Eligibility Criteria

• Age: 30 Years - 70 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Qinyang LIU, MBBS, MSc, FRCSEd

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Qinyang LIU, MBBS, MSc, FRCSEd

CONTACT

+852-3505-2625; alexliu@surgery.cuhk.edu.hk

Chi Fai NG, MBChB, MD, FRCSEd

CONTACT

+852-3505-2625; ngcf@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 27, 2026
• Study Start: July 16, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)