Menu
Not yet recruiting NCT07728071

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

No phase Interventional BPH (Benign Prostatic Hyperplasia)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TURP using the Aulea Veloxion™ Disposable Resectoscope System, Aulea Veloxion™ Disposable Resectoscope System.
Who it may be relevant to
Registry conditions: BPH (Benign Prostatic Hyperplasia). Basic parameters: 30 years — 70 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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

  • 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 i
  • 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

Primary outcome measures

  • Difference in total procedure time versus a pre-specified benchmark [Time frame: Perioperative]
  • Difference in case cost versus a pre-specified benchmark [Time frame: Perioperative]
Secondary outcome measures (7)
  • Total Resection time [Time frame: Intra-operative]
  • The Instrument exchanges time [Time frame: Intra-operative]
  • The Visibility score [Time frame: Intra-operative]
  • Adverse event [Time frame: Within post-operative 30 days]
  • The cost per case [Time frame: Intra-operative]
  • Staff usability scores [Time frame: Intra-operative]
  • Total procedure time [Time frame: intra-operative]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Prince of Wales Hospital — Shatin

Identifiers

NCT: NCT07728071 · CRE-2026.117

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗