Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia... | NCT07728071

NCT07728071

Overview

NCT ID: NCT07728071
Lead Sponsor: Chinese University of Hong KongOTHER
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)
Brief Summary: Prospective, single-arm, single-site, post-market device study; all procedures use Veloxion™ per IFU.
Conditions: BPH (Benign Prostatic Hyperplasia)
Interventions: TURP using the Aulea Veloxion™ Disposable Resectoscope System
Aulea Veloxion™ Disposable Resectoscope System

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers?: No
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.

Central Contacts: Alex Qinyang LIU, MBBS, MSc, FRCSEdContact
alexliu@surgery.cuhk.edu.hk