Neuflo System for the Treatment of BPH (NCT05884580) | Clinical Trial Compass
TerminatedNot Applicable
Neuflo System for the Treatment of BPH
Stopped: A design change was required following the first treatment. The design concept was not feasible.
New Zealand1 participantsStarted 2023-11-10
Plain-language summary
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.
Who can participate
Age range45 Years
SexMALE
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Inclusion criteria
✓. Males aged 45 years of age or older
✓. IPSS score of 13 or higher
✓. Eligible uroflow with unadjusted or adjusted peak flow rate of equal to or less than 13ml/sec with a corresponding:
✓. voided volume of at least 100 ml, and,
✓. Post Void Residual (PVR) of 250 ml or less
✓. Prostate volume of 25-80 cm3, inclusive as measured by ultrasound or MRI
✓. Prostatic sagittal length of 3.2 cm or greater, as measured by ultrasound or MRI
✓. Prostatic transverse width of 3.5 cm or greater as measured by ultrasound or MRI
Exclusion criteria
✕. Outlet obstruction due to an enlarged middle lobe or significant central gland of the prostate
✕. Significant transverse asymmetry of prostatic lateral lobes
What they're measuring
1
Effectiveness: Relief of BPH symptoms as measured by International Prostate Symptom Score (IPSS)