BPH (Benign Prostatic Hyperplasia)NCT07728071
Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
A study testing TURP using the Aulea Veloxion™ Disposable Resectoscope System and Aulea Veloxion™ Disposable Resectoscope System in people with BPH (Benign Prostatic Hyperplasia), run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Prospective, single-arm, single-site, post-market device study; all procedures use Veloxion™ per IFU. Read more about this study
- Who is it for?
- Ages 30 to 70 years, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia)
- What is being tested?
- TURP using the Aulea Veloxion™ Disposable Resectoscope System and Aulea Veloxion™ Disposable Resectoscope System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Oct 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Qinyang LIU, MBBS, MSc, FRCSEd, +852-3505-2625, alexliu@surgery.cuhk.edu.hk
About this study
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)
Prospective, single-arm, single-site, post-market device study; all procedures use Veloxion™ per IFU.
Read the 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).
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Being tested
- TURP using the Aulea Veloxion™ Disposable Resectoscope System, Aulea Veloxion™ Disposable Resectoscope System
- Keywords
- Surgical management of BPH
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TURP using the Aulea Veloxion™ Disposable Resectoscope SystemProcedure or surgery
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 in a motorized and highly effective manner. This study is designed to prospectively characterize operational efficiency in real-world BPH resections using the cleared device platform.
Aulea Veloxion™ Disposable Resectoscope SystemDevice
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 and extended equipment life. This system allows transurethral resection of prostate to be performed in a motorized and highly effective manner. This study is designed to prospectively characterize operational efficiency in real-world BPH resections using the cleared device platform.
| Study group | Role | What they receive |
|---|---|---|
| Aulea Veloxion™ Disposable Resectoscope System | Experimental | Not described Receives: Procedure: TURP using the Aulea Veloxion™ Disposable Resectoscope System; Device: Aulea Veloxion™ Disposable Resectoscope System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in total procedure time versus a pre-specified benchmark
Derived from historical standard reusable resectoscope TURP/TURP-like procedures at the same site, tested against a superiority margin
Measured: Perioperative
Difference in case cost versus a pre-specified benchmark
Derived from historical standard reusable resectoscope TURP/TURP-like procedures at the same site, tested against a superiority margin
Measured: Perioperative
Secondary outcomes (7)
Total Resection time
The cumulative electrosurgery activation time (minutes) from generator logs and video annotation.
Measured: Intra-operative
The Instrument exchanges time
The count and cumulative time with scope out-of-field; standardized categories (loop, electrode, sheath, camera).
Measured: Intra-operative
The Visibility score
Assessed by the surgeon-rated 5-point Likert per 15-minute epoch; total irrigation volume; number of bag exchanges; "red-out" events.
Measured: Intra-operative
Adverse event
By "Clavien-Dindo Classification"
Measured: Within post-operative 30 days
The cost per case
equipment, facility, consumables, device, reprocessing, repair, maintenance, rental (if applicable), staff cost to perform the surgery
Measured: Intra-operative
Staff usability scores
By OR nurse and scrub tech 5-point Likert for setup ease, troubleshooting, case flow.
Measured: Intra-operative
Total procedure time
The time from scope insertion to final scope removal (minutes) from OR time logs/video time stamps.
Measured: intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start2 Oct 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH (Benign Prostatic Hyperplasia)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Qinyang Liu, Chinese University of Hong Kong
- Investigators
- Qinyang LIU, MBBS, MSc, FRCSEd, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728071
- Sponsor's protocol ID
- CRE-2026.117
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07728071
- Acronym / sponsor ID
- CRE-2026.117
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Keywords
- Surgical management of BPH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 2 Oct 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aulea Veloxion™ Disposable Resectoscope System | Experimental | Procedure: TURP using the Aulea Veloxion™ Disposable Resectoscope System, Device: Aulea Veloxion™ Disposable Resectoscope System |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TURP using the Aulea Veloxion™ Disposable Resectoscope SystemTURP 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 in a motorized and highly effective manner. This study is designed to prospectively characterize operational efficiency in real-world BPH resections using the cleared device platform. | Procedure or surgery | Aulea Veloxion™ Disposable Resectoscope System |
| Aulea Veloxion™ Disposable Resectoscope SystemVeloxion™ 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 and extended equipment life. This system allows transurethral resection of prostate to be performed in a motorized and highly effective manner. This study is designed to prospectively characterize operational efficiency in real-world BPH resections using the cleared device platform. | Device | Aulea Veloxion™ Disposable Resectoscope System |
Primary outcome
Difference in total procedure time versus a pre-specified benchmark
Time frame: Perioperative
Derived from historical standard reusable resectoscope TURP/TURP-like procedures at the same site, tested against a superiority margin
Difference in case cost versus a pre-specified benchmark
Time frame: Perioperative
Derived from historical standard reusable resectoscope TURP/TURP-like procedures at the same site, tested against a superiority margin
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qinyang LIU, MBBS, MSc, FRCSEd principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TURP using the Aulea Veloxion™ Disposable Resectoscope System and Aulea Veloxion™ Disposable Resectoscope System in people with BPH (Benign Prostatic Hyperplasia), run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex Qinyang LIU, MBBS, MSc, FRCSEd (+852-3505-2625, alexliu@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in total procedure time versus a pre-specified benchmark (time frame: Perioperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.