Clinical trial Recruiting at 1 site Interventional Ages 30 to 70 Men only

Veloxion disposable resectoscope system for BPH surgery

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)

Run by Chinese University of Hong Kong · NCT07728071 · Data updated 2026-11-12

This study tests whether the Veloxion disposable resectoscope helps perform endoscopic BPH surgery more efficiently and safely in men with moderate to large prostates.

Quick facts

Study typeInterventional
Ages30 Years to 70 Years
SexMen only
Enrollment20 (estimated)
SponsorChinese University of Hong Kong
Academic / other
Locations1 site (Shatin)
StatusRecruiting
StartedOctober 2, 2026
Main results expectedJune 30, 2027
Study endsDecember 31, 2027
Registry record updatedOctober 27, 2026
Trial IDNCT07728071 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men aged 30-70 with symptomatic BPH and prostate volume 20–120 mL who are deemed suitable for endoscopic resection or vaporization and able to complete follow-up.

Probably not a fit

Patients with prostate cancer, recent prostate surgery or implants affecting anatomy, active untreated infection, coagulation problems, or significant comorbidity may not benefit from this device approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm, single-site post-market device study evaluating the Veloxion disposable resectoscope used during endoscopic treatment of benign prostatic hyperplasia. The primary focus is operational efficiency and safety, with follow-up visits at 2 weeks and 1 month to capture safety data, device-related adverse events, any need for reinterventions, and usability feedback. All procedures use the device per the manufacturer’s instructions for use. Eligible participants are men aged 30-70 with symptomatic BPH and prostate volume between 20 and 120 mL who are suitable for endoscopic resection or vaporization. Exclusion criteria include prostate cancer requiring oncologic care, recent prostate surgery or implants affecting anatomy, active infection, coagulation issues, or significant medical comorbidity that would preclude anesthesia or endoscopy.

Why it matters

Potential benefit: If successful, patients could experience safer or quicker endoscopic BPH surgery with the Veloxion system and improved procedural efficiency.

How similar studies have gone: Prior post-market device evaluations in urology have shown variable but informative safety and usability signals for disposable endoscopic tools; this study adds prospective single-site data for Veloxion in BPH.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Prince of Wales Hospital
    Shatin, Hong Kong
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.