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NOT YET RECRUITING
NCT07728071
NA

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

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

Summary

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

Official 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)

Key Details

Gender

MALE

Age Range

30 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-07-16

Completion Date

2027-12-31

Last Updated

2026-07-27

Healthy Volunteers

No

Interventions

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.

Locations (1)

Prince of Wales Hospital

Shatin, Hong Kong