Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05443451
Other study ID # CRE 2022.249
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 8, 2022
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source Chinese University of Hong Kong
Contact Peter Ka-Fung CHIU, FRCS, PhD
Phone 3505-2625
Email peterchiu@surgery.cuhk.eud.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Device:
3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH
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.

Locations

Country Name City State
Hong Kong Prince of Wales Hospital Hong Kong

Sponsors (2)

Lead Sponsor Collaborator
Chinese University of Hong Kong Koelis

Country where clinical trial is conducted

Hong Kong, 

References & Publications (12)

See more »

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events (AE) and serious adverse events (SAE) related to the treatment The severity of AE is grade by Clavien-Dindo classification. At 1 month
Secondary Prostate volume change Prostate volume change after treatment Baseline, 3 months, 6 months
Secondary 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. Baseline, 1 month, 3 months, 6 months
Secondary 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. Baseline, 1 month, 3 months, 6 months
Secondary 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. Baseline, 1 month, 3 months, 6 months
Secondary Change in urodynamic in uroflowmetry Change in urodynamic function assessed by uroflowmetry, parameters include voided volume, maximum flow rate and post-void residual. Baseline, 1 month, 3 months, 6 months
Secondary PSA change PSA change after treatment Baseline, 3 months, 6 months
Secondary Average patient post-operative pain level Assessed by a pain numeric rating scale, Score 0-10, the higher score the worsen pain Baseline, 2 and 4 hours after the procedure and at 1-week
Secondary Patient quality of life Assessed with the EQ-5D-5L questionnaire, the higher the score the better in quality of life Baseline, 1-week, 1-month, 3-month, and 6-month,
Secondary Patient satisfaction Assessed with the PGI-I questionnaire,the lower score the more satisfaction Baseline, 1-week, 1-month, 3-month, and 6-month,
Secondary Ease of the procedure measured with a score chosen by the operator 1: easy, 2: moderate, 3: difficult Post procedure immediately
Secondary Ablation treatment time Duration of the ablation procedure Intra-operation
Secondary Length of hospital stay Total number of days of hospitalization for the surgical procedure The total number of days of hospitalization for this surgical procedure up to day 30 after the procedure]
Secondary Operation time Duration of patients stay in Operation Room Intra-operation
See also
  Status Clinical Trial Phase
Recruiting NCT04288427 - 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy N/A
Not yet recruiting NCT05017285 - Ejaculation Preservation After Laser Enucleation Prostate N/A
Completed NCT02778243 - Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level N/A
Completed NCT04212403 - Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB) N/A
Recruiting NCT05440981 - Implanted Nitinol Device (iTind) System in Chinese Males With Lower Urinary Tract Symptom Secondary to BPH N/A
Recruiting NCT05531240 - Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE) N/A
Recruiting NCT03176017 - Ejaculatory Sparing Transurethral Incision Of The Prostate (ES-TUIP) Versus Conventional TUIP N/A
Completed NCT02244294 - FLOMAX® Versus Placebo, in Male Patients With Acute Urinary Retention Related to Benign Prostatic Hyperplasia (BPH) Phase 2
Recruiting NCT03966950 - Use of Melatonin for Preventing POCD in Transurethral Prostate Resection Under Spinal Anesthesia N/A
Enrolling by invitation NCT06469125 - Anatomic Endoscopic Prostate Enucleation and BICEP Classification
Recruiting NCT06116851 - Prostate Metabolism, Cancer Risk and Gut Microbiota
Completed NCT04781985 - Prostatic Resection Cavity Stone Post Transurethral Resection of the Prostate (TURP). A Rare Case Scenario N/A
Not yet recruiting NCT01876836 - Clasic Laryngeal Mask Airway(C-LMA) and I-gel Releated Regurgitation and Complications Phase 4
Completed NCT05941260 - Standardization of Prostatic Resection by Virtual Computational Reconstruction and Computational Flow Dynamics
Completed NCT04580628 - Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)
Completed NCT04848181 - The Effect of Pre-operative Use of Finasteride Versus Cyproterone Acetate on Blood Loss With Transurethral Resection of Prostate Early Phase 1
Recruiting NCT06224218 - Prostate Single Port & Laser Enucleation Comparison Trial N/A
Completed NCT04781049 - Transperineal Laser Ablation vs Transurethral Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial N/A
Completed NCT05059431 - The Effect of Human Prostate Tissue on Platelet Activation
Completed NCT05108662 - Inflammatory Markers: HOLEP Versus TURP N/A