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

Conditions: BPH (Benign Prostatic Hyperplasia)

Sex: Male

Ages: 30 Years – 70 Years

Healthy volunteers: No

Phase: NA

Enrollment: 20

Sponsor: Chinese University of Hong Kong

Location: Prince of Wales Hospital Shatin

Summary

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

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07728071). StuddyBuddy aggregates publicly available trial information.