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NCT05884580
Neuflo System for the Treatment of BPH
NA trial testing Neuflo BPH Treatment System in Benign Prostatic Hyperplasia in 1 participant. Terminated before completion.
9 January 2026
Quick facts
| Lead sponsor | ProstaCare Pty Ltd |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 10 November 2023 |
| Primary completion | 9 January 2026 |
| Estimated completion | 10 January 2026 |
| Sites | 1 location across New Zealand |
Drugs / interventions tested
- Neuflo BPH Treatment System
Conditions studied
- Benign Prostatic Hyperplasia — all drugs for Benign Prostatic Hyperplasia →
- Lower Urinary Tract Symptoms — all drugs for Lower Urinary Tract Symptoms →
Sponsor
ProstaCare Pty Ltd
Who can join
45 and older, male only, with Benign Prostatic Hyperplasia or Lower Urinary Tract Symptoms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical study is to assess the effectiveness and safety of the Neuflo System for the treatment of benign prostatic hyperplasia (BPH). The main questions it aims to answer are: * Can treatment with the Neuflo System lead to at least a 30% improvement in lower urinary tract symptoms (LUTS) secondary to BPH, as measured by the international prostate symptom score (IPSS) at 3 months after treatment which is sustained for 12 months? * Is treatment with the Neuflo System tolerable to the patient, as measured by visual analog score (VAS) for pain before and after treatment and procedural medication requirements? * Is treatment with the Neuflo System safe, as measured by the incidence and severity of device or procedural related serious adverse events. Participants will be enrolled in the study over a 6 month period. Each participant will be treated with the Neuflo System and assessed at 3 and 12 months following treatment. A subgroup of patients will have an MRI at 1 week to assess the volume and location of ablated tissue. The duration of the study is expected to be 18 months.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05884580
- Europe PMC full search
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Related trials
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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
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 NCT05884580 (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 ProstaCare Pty Ltd
- Last refreshed: 4 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05884580.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing