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NCT03938194
Waterjet Prostate Ablation
NA trial testing Aquablation in Benign Prostatic Hyperplasia in 20 participants. Terminated before completion.
17 May 2021
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 25 April 2019 |
| Primary completion | 17 May 2021 |
| Estimated completion | 21 October 2021 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- Aquablation
Conditions studied
- Benign Prostatic Hyperplasia — all drugs for Benign Prostatic Hyperplasia →
Sponsor
Chinese University of Hong Kong
Who can join
Adults 50 to 75, male only, with Benign Prostatic Hyperplasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Introduction Men with enlarged prostates commonly experience lower urinary tract symptoms and may go on to develop complications such as acute urinary retention (AUR). Surgery is the standard treatment option required to remove the enlarged prostates and to rectify such complications. Transurethral resection of prostate (TURP) was first performed over 80 years ago and is still regarded as the "gold standard" for the treatment of benign prostatic enlargement (BPE) in prostates between 30 and 80ml. While TURP results in an improvement in symptoms, perioperative morbidity and long-term complications can include postoperative bleeding, urinary retention, incontinence, urethral strictures, erectile dysfunction, and ejaculatory dysfunction. Aquablation, a novel minimally invasive water ablation therapy combining image guidance and robotics (AQUABEAM®, Procept BioRobotics, Redwood Shores, CA, USA) for the targeted and heatfree removal of prostate tissue is one of the efforts in the development of new technology in recent years to replicate the effectiveness of TURP and at the same time with an improved safety profile. In this study, investigators plan to evaluate the feasibility and safety of Aquablation in the management of AUR secondary to BPE. Method 20 participants are expected in this study. After patients consent to participate in the study, they will go through Aquablation under general anaesthesia or spinal anaesthesia. The ablation is delivered by transurethral means. After the procedure, subject is expected to go home on the following day. Subject will be assessed 3 months and 6 months after the procedure. Follow-up assessment includes blood tests, prostate ultrasound and urodynamic study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Other trials of Aquablation
Trials testing the same drug.
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- NCT03123250 — Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II · NA · completed
Other recruiting trials for Benign Prostatic Hyperplasia
Currently open trials in the same condition.
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- NCT06852859 — Patient-reported Pain and Symptom Relief During Three Months After Surgery for Benign Prostatic Hyperplasia · recruiting
- NCT06849258 — A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms · NA · recruiting
Other Chinese University of Hong Kong trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03938194 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese University of Hong Kong
- Last refreshed: 14 January 2022
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