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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age30-70
SponsorChinese University of Hong Kong

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • TURP using the Aulea Veloxion™ Disposable Resectoscope System
  • Aulea Veloxion™ Disposable Resectoscope System

Treatment groups

20 Participants
are divided into 1 treatment group