Prostate HyperplasiaNCT05443451

BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

A study testing 3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH in people with Prostate Hyperplasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a pilot study on applying 3D-Ultrasound-Guided Transperineal Microwave needle ablation for men with symptomatic benign prostatic hyperplasia (BPH). Read more about this study

Who is it for?: Ages 50 years and older, men only
Conditions the study is for: Prostate Hyperplasia
What is being tested?: 3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteHong Kong
Study dates: 8 Sep 2022to 30 Oct 2023
Phase: Interventional
Are there results?: None posted in the registry

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 50 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Age over 50 years.
Benign prostatic hyperplasia with prostate size 30-80 cc
IPSS ≥ 14
PSA ≤ 4 ng/mL or PSA >4 ng/mL with no evidence of suspicious lesion on mpMRI
Maximum urine flow rate (Qmax) ≤ 15 mL/s.
Post-Void Residual ≤ 150 mL.
Patient suitable for IV sedation and/or spinal anaesthesia and/or general anaesthesia and focal microwave ablation.
Informed written consent

Who cannot join

Significant intravesical median lobe hyperplasia.
Suspicious lesion on mpMRI prostate
History of prostate, bladder or urethral surgery.
History of prostate cancer
Presence of stones, bladder diverticulum and/or bladder tumor
History of long-term indwelling catheter.

Show all 16Show fewer

Urethral stricture
Known coagulopathy or on anticoagulant
Presence of a pacemaker.
Active infection
Dysuria due to bladder dysfunction.
Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit.
Neurological disorders that would impact bladder function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injury).
Contraindications for mpMRI exam or MR contrast
Acute and/or chronic renal failure (GFR <50 ml/min and serum creatinine > 1.5 mg/d).
Patient currently participating in another interventional clinical trial.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Prince of Wales Hospital
Hong Kong

Other trials in Hong Kong

About this study

Official title: 3D-Ultrasound-Guided Transperineal Microwave Needle Ablation for Men With Symptomatic Benign Prostatic Hyperplasia

This is a pilot study on applying 3D-Ultrasound-Guided Transperineal Microwave needle ablation for men with symptomatic benign prostatic hyperplasia (BPH).

Read the detailed description

This is a prospective, single centre, open-label and non-comparative trial planned on 12 patients. Patients who fit inclusion criteria would be recruited and offered microwave ablation to the enlarged prostate. The patients will be closely followed up to 6 months after treatment with serial assessment on safety and efficacy.

Conditions: Prostate Hyperplasia
Being tested: 3D-Ultrasound-Guided Transperineal Microwave needle ablation 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.

3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPHDevice
The procedure will consist of a focal, transperineal, targeted microwave ablation of prostate adenoma. Surgical planning using 3D transrectal ultrasound and real-time monitoring of the ablation would preserve key anatomical landmarks such as the bladder neck, prostatic urethra and verumontanum. The Organ-Based Tracking (OBT®) patented technology would provide a 3D prostate model to facilitate real-time navigation-guided ablation and accurate mapping of treatment zone. The procedure will be conducted under general anaesthesia, spinal anaesthesia, or monitored anaesthetic care / sedation. An average number of one to three microwave ablations per lobe is expected, depending on the size and shape of each prostate. The microwave ablation parameters will be chosen intraoperatively. A urinary catheter may be necessary immediately after the procedure. Patients are planned to be discharged on the same day or the day after when they are fit for discharge.

Study groups in NCT05443451
Study group	Role	What they receive
Transperineal Microwave needle ablation for symptomatic BPH	Experimental	Not described Receives: Device: 3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse events (AE) and serious adverse events (SAE) related to the treatment
The severity of AE is grade by Clavien-Dindo classification.
Measured: At 1 month

Secondary outcomes (13)

Prostate volume change
Prostate volume change after treatment
Measured: Baseline, 3 months, 6 months
Urinary symptoms measured by International Prostate Symptom Score (IPSS) score
Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score, the more worse symptom.
Measured: Baseline, 1 month, 3 months, 6 months
Erectile function measured by International Index of Erectile Function 5-item version (IIEF-5) score
Change in International Index of Erectile Function 5 questionnaire score (ranges from 0 to 25). The higher score, the more worse symptom.
Measured: Baseline, 1 month, 3 months, 6 months
Ejaculatory function measured by MSHQ-EjD-SF (function and bother) score
Change in MSHQ-EjD-SF questionnaire score (Range from 1-15 for function and and 0-5 for bother). The higher score, the more worse symptom.
Measured: Baseline, 1 month, 3 months, 6 months
Change in urodynamic in uroflowmetry
Change in urodynamic function assessed by uroflowmetry, parameters include voided volume, maximum flow rate and post-void residual.
Measured: Baseline, 1 month, 3 months, 6 months
PSA change
PSA change after treatment
Measured: Baseline, 3 months, 6 months
Average patient post-operative pain level
Assessed by a pain numeric rating scale, Score 0-10, the higher score the worsen pain
Measured: Baseline, 2 and 4 hours after the procedure and at 1-week
Patient quality of life
Assessed with the EQ-5D-5L questionnaire, the higher the score the better in quality of life
Measured: Baseline, 1-week, 1-month, 3-month, and 6-month,
Patient satisfaction
Assessed with the PGI-I questionnaire,the lower score the more satisfaction
Measured: Baseline, 1-week, 1-month, 3-month, and 6-month,
Ease of the procedure measured with a score chosen by the operator
1: easy, 2: moderate, 3: difficult
Measured: Post procedure immediately
Ablation treatment time
Duration of the ablation procedure
Measured: Intra-operation
Length of hospital stay
Total number of days of hospitalization for the surgical procedure
Measured: The total number of days of hospitalization for this surgical procedure up to day 30 after the procedure]
Operation time
Duration of patients stay in Operation Room
Measured: Intra-operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 202230 Oct 2023

First posted5 Jul 2022
Study start8 Sep 2022
Primary completion5 Oct 2023
Study completion30 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Prostate HyperplasiaStudies 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: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05443451
Sponsor's protocol ID: CRE 2022.249
Status last verified: Jun 2026
First submitted: 22 Jun 2022
Last updated: 6 Nov 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Zhang W, Zhang X, Li H, Wu F, Wang H, Zhao M, Hu H, Xu K. Prevalence of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) in China: results from the China Health and Retirement Longitudinal Study. BMJ Open. 2019 Jun 19;9(6):e022792. doi: 10.1136/bmjopen-2018-022792.
PubMed 31221864
Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Nandy I, Morrill BB, Gagnier RP, Montorsi F; CombAT Study Group. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol. 2010 Jan;57(1):123-31. doi: 10.1016/j.eururo.2009.09.035. Epub 2009 Sep 19.
PubMed 19825505
Ng CF, Yee CH, Chan CK, Wong HM, Chiu PK, Tsu JH, Teoh JY, Ho KL. Bipolar transurethral vapourisation versus monopolar transurethral resection of prostate: a randomised controlled trial. Hong Kong Med J. 2017 Jun;23 Suppl 2(3):32-34. No abstract available.
PubMed 29938669
Yee CH, Wong JH, Chiu PK, Chan CK, Lee WM, Tsu JH, Teoh JY, Ng CF. Short-stay transurethral prostate surgery: A randomized controlled trial comparing transurethral resection in saline bipolar transurethral vaporization of the prostate with monopolar transurethral resection. Asian J Endosc Surg. 2015 Aug;8(3):316-22. doi: 10.1111/ases.12197. Epub 2015 Jun 3.
PubMed 26042336
Madersbacher S, Lackner J, Brossner C, Rohlich M, Stancik I, Willinger M, Schatzl G; Prostate Study Group of the Austrian Society of Urology. Reoperation, myocardial infarction and mortality after transurethral and open prostatectomy: a nation-wide, long-term analysis of 23,123 cases. Eur Urol. 2005 Apr;47(4):499-504. doi: 10.1016/j.eururo.2004.12.010. Epub 2005 Jan 23.
PubMed 15774249
Raizenne BL, Zheng X, Mao J, Zorn KC, Cho A, Elterman D, Bhojani N, Sedrakyan A, Chughtai B. Real-world data comparing minimally invasive surgeries for benign prostatic hyperplasia. World J Urol. 2022 May;40(5):1185-1193. doi: 10.1007/s00345-021-03926-9. Epub 2022 Feb 2.
PubMed 35107632
Chughtai B, Elterman D, Shore N, Gittleman M, Motola J, Pike S, Hermann C, Terrens W, Kohan A, Gonzalez RR, Katz A, Schiff J, Goldfischer E, Grunberger I, Tu LM, Alshak MN, Kaminetzky J. The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial. Urology. 2021 Jul;153:270-276. doi: 10.1016/j.urology.2020.12.022. Epub 2020 Dec 26.
PubMed 33373708
McVary KT, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Pliskin M, Beahrs JR, Prall D, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Tadros NN, Gange SN, Roehrborn CG. Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2021 Sep;206(3):715-724. doi: 10.1097/JU.0000000000001778. Epub 2021 Apr 19.
PubMed 33872051
Chiu PK, Lo KL, Teoh JY, Ma SF, Leung CH, Wong HF, Li KM, Sae-Lo K, Kwok SW, Li SY, Yee CH, Hou SM, Ng CF. Sectoral cancer detection and tolerability of freehand transperineal prostate biopsy under local anaesthesia. Prostate Cancer Prostatic Dis. 2021 Jun;24(2):431-438. doi: 10.1038/s41391-020-00293-1. Epub 2020 Sep 30.
PubMed 32999465
Barry Delongchamps N, Schull A, Anract J, Abecassis JP, Zerbib M, Sibony M, Jilet L, Abdoul H, Goffin V, Peyromaure M. Feasibility and safety of targeted focal microwave ablation of the index tumor in patients with low to intermediate risk prostate cancer: Results of the FOSTINE trial. PLoS One. 2021 Jul 14;16(7):e0252040. doi: 10.1371/journal.pone.0252040. eCollection 2021.
PubMed 34260598
Lo KL, Chui KL, Leung CH, Ma SF, Lim K, Ng T, Wong J, Li JKM, Mak SK, Ng CF. Outcomes of transperineal and transrectal ultrasound-guided prostate biopsy. Hong Kong Med J. 2019 Jun;25(3):209-215. doi: 10.12809/hkmj187599. Epub 2019 May 29.
PubMed 31178436
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
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RecruitingObservational study
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All Prostate Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 3D-Ultrasound-Guided Transperineal Microwave Needle Ablation for Men With Symptomatic Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT05443451
Acronym / sponsor ID: CRE 2022.249
Conditions: Prostate Hyperplasia
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Chinese University of Hong KongUniversity, hospital or other
Collaborators: Koelis
Study start: 8 Sep 2022 (actual)
Primary completion: 5 Oct 2023 (actual)
Study completion: 30 Oct 2023 (actual)
First posted: 5 Jul 2022 (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.

This is a pilot study on applying 3D-Ultrasound-Guided Transperineal Microwave needle ablation for men with symptomatic benign prostatic hyperplasia (BPH).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Transperineal Microwave needle ablation for symptomatic BPH	Experimental	Device: 3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age over 50 years.
Benign prostatic hyperplasia with prostate size 30-80 cc
IPSS ≥ 14
PSA ≤ 4 ng/mL or PSA >4 ng/mL with no evidence of suspicious lesion on mpMRI
Maximum urine flow rate (Qmax) ≤ 15 mL/s.

Key exclusion criteria (16 listed)

Significant intravesical median lobe hyperplasia.
Suspicious lesion on mpMRI prostate
History of prostate, bladder or urethral surgery.
History of prostate cancer
Presence of stones, bladder diverticulum and/or bladder tumor

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
3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPHThe procedure will consist of a focal, transperineal, targeted microwave ablation of prostate adenoma. Surgical planning using 3D transrectal ultrasound and real-time monitoring of the ablation would preserve key anatomical landmarks such as the bladder neck, prostatic urethra and verumontanum. The Organ-Based Tracking (OBT®) patented technology would provide a 3D prostate model to facilitate real-time navigation-guided ablation and accurate mapping of treatment zone. The procedure will be conducted under general anaesthesia, spinal anaesthesia, or monitored anaesthetic care / sedation. An average number of one to three microwave ablations per lobe is expected, depending on the size and shape of each prostate. The microwave ablation parameters will be chosen intraoperatively. A urinary catheter may be necessary immediately after the procedure. Patients are planned to be discharged on the same day or the day after when they are fit for discharge.	Device	Transperineal Microwave needle ablation for symptomatic BPH

Primary outcome

Adverse events (AE) and serious adverse events (SAE) related to the treatment
Time frame: At 1 month
The severity of AE is grade by Clavien-Dindo classification.

13 secondary outcomes

Prostate volume change
Time frame: Baseline, 3 months, 6 months
Urinary symptoms measured by International Prostate Symptom Score (IPSS) score
Time frame: Baseline, 1 month, 3 months, 6 months
Erectile function measured by International Index of Erectile Function 5-item version (IIEF-5) score
Time frame: Baseline, 1 month, 3 months, 6 months
Ejaculatory function measured by MSHQ-EjD-SF (function and bother) score
Time frame: Baseline, 1 month, 3 months, 6 months
Change in urodynamic in uroflowmetry
Time frame: Baseline, 1 month, 3 months, 6 months
PSA change
Time frame: Baseline, 3 months, 6 months
Average patient post-operative pain level
Time frame: Baseline, 2 and 4 hours after the procedure and at 1-week
Patient quality of life
Time frame: Baseline, 1-week, 1-month, 3-month, and 6-month,
Patient satisfaction
Time frame: Baseline, 1-week, 1-month, 3-month, and 6-month,
Ease of the procedure measured with a score chosen by the operator
Time frame: Post procedure immediately
Ablation treatment time
Time frame: Intra-operation
Length of hospital stay
Time frame: The total number of days of hospitalization for this surgical procedure up to day 30 after the procedure]
Operation time
Time frame: Intra-operation

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
Background: PubMed 31221864Zhang W, Zhang X, Li H, Wu F, Wang H, Zhao M, Hu H, Xu K. Prevalence of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) in China: results from the China Health and Retirement Longitudinal Study. BMJ Open. 2019 Jun 19;9(6):e022792. doi: 10.1136/bmjopen-2018-022792.
Background: PubMed 19825505Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Nandy I, Morrill BB, Gagnier RP, Montorsi F; CombAT Study Group. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol. 2010 Jan;57(1):123-31. doi: 10.1016/j.eururo.2009.09.035. Epub 2009 Sep 19.
Background: PubMed 29938669Ng CF, Yee CH, Chan CK, Wong HM, Chiu PK, Tsu JH, Teoh JY, Ho KL. Bipolar transurethral vapourisation versus monopolar transurethral resection of prostate: a randomised controlled trial. Hong Kong Med J. 2017 Jun;23 Suppl 2(3):32-34. No abstract available.
Background: PubMed 26042336Yee CH, Wong JH, Chiu PK, Chan CK, Lee WM, Tsu JH, Teoh JY, Ng CF. Short-stay transurethral prostate surgery: A randomized controlled trial comparing transurethral resection in saline bipolar transurethral vaporization of the prostate with monopolar transurethral resection. Asian J Endosc Surg. 2015 Aug;8(3):316-22. doi: 10.1111/ases.12197. Epub 2015 Jun 3.
Background: PubMed 15774249Madersbacher S, Lackner J, Brossner C, Rohlich M, Stancik I, Willinger M, Schatzl G; Prostate Study Group of the Austrian Society of Urology. Reoperation, myocardial infarction and mortality after transurethral and open prostatectomy: a nation-wide, long-term analysis of 23,123 cases. Eur Urol. 2005 Apr;47(4):499-504. doi: 10.1016/j.eururo.2004.12.010. Epub 2005 Jan 23.
Background: PubMed 35107632Raizenne BL, Zheng X, Mao J, Zorn KC, Cho A, Elterman D, Bhojani N, Sedrakyan A, Chughtai B. Real-world data comparing minimally invasive surgeries for benign prostatic hyperplasia. World J Urol. 2022 May;40(5):1185-1193. doi: 10.1007/s00345-021-03926-9. Epub 2022 Feb 2.
Background: PubMed 33373708Chughtai B, Elterman D, Shore N, Gittleman M, Motola J, Pike S, Hermann C, Terrens W, Kohan A, Gonzalez RR, Katz A, Schiff J, Goldfischer E, Grunberger I, Tu LM, Alshak MN, Kaminetzky J. The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial. Urology. 2021 Jul;153:270-276. doi: 10.1016/j.urology.2020.12.022. Epub 2020 Dec 26.
Background: PubMed 33872051McVary KT, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Pliskin M, Beahrs JR, Prall D, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Tadros NN, Gange SN, Roehrborn CG. Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2021 Sep;206(3):715-724. doi: 10.1097/JU.0000000000001778. Epub 2021 Apr 19.
Background: PubMed 32999465Chiu PK, Lo KL, Teoh JY, Ma SF, Leung CH, Wong HF, Li KM, Sae-Lo K, Kwok SW, Li SY, Yee CH, Hou SM, Ng CF. Sectoral cancer detection and tolerability of freehand transperineal prostate biopsy under local anaesthesia. Prostate Cancer Prostatic Dis. 2021 Jun;24(2):431-438. doi: 10.1038/s41391-020-00293-1. Epub 2020 Sep 30.
Background: PubMed 34260598Barry Delongchamps N, Schull A, Anract J, Abecassis JP, Zerbib M, Sibony M, Jilet L, Abdoul H, Goffin V, Peyromaure M. Feasibility and safety of targeted focal microwave ablation of the index tumor in patients with low to intermediate risk prostate cancer: Results of the FOSTINE trial. PLoS One. 2021 Jul 14;16(7):e0252040. doi: 10.1371/journal.pone.0252040. eCollection 2021.
Background: PubMed 31178436Lo KL, Chui KL, Leung CH, Ma SF, Lim K, Ng T, Wong J, Li JKM, Mak SK, Ng CF. Outcomes of transperineal and transrectal ultrasound-guided prostate biopsy. Hong Kong Med J. 2019 Jun;25(3):209-215. doi: 10.12809/hkmj187599. Epub 2019 May 29.
Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
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. This study is not recruiting at the moment.

Peter Ka-Fung CHIU, FRCS, PhD 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 3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH in people with Prostate 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 8 inclusion and 16 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: finished, as of the sponsor's last update on 6 Nov 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AE) and serious adverse events (SAE) related to the treatment (time frame: At 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05443451, which also lists 12 linked publications.

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 6 Nov 2026.