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

NCT07728071 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-03

No results posted yet for this study

Summary

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

Conditions

  • BPH (Benign Prostatic Hyperplasia)

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.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Qinyang LIU, MBBS, MSc, FRCSEd · Chinese University of Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-16
Primary Completion
2027-06-30
Completion
2027-12-31
FDA Device
Yes

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07728071 on ClinicalTrials.gov