Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL) (NCT03605745) | Clinical Trial Compass
TerminatedNot Applicable
Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL)
Stopped: Sponsor decided to terminate the study due to business reasons
United States47 participantsStarted 2018-06-19
Plain-language summary
Prospective, multicenter, single arm clinical trial designed to evaluate the safety of the Rezūm System in treating subjects with symptomatic BPH for prostate sizes \>80cm3 and ≤150 cm3.
Who can participate
Age range50 Years
SexMALE
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Inclusion criteria
✓. Male subjects ≥ 50 years of age who have symptomatic BPH.
✓. International Prostate Symptom Score (IPSS) score ≥ 13.
✓. Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 12 ml/sec with minimum voided volume of ≥ 125 ml.
✓. Post-void residual (PVR) ≤300 ml.
✓. Prostate volume \>80 cm3 to ≤150 cm3
Exclusion criteria
✕. Any prior invasive prostate intervention (e.g., "Radiofrequency" thermotherapy, balloon, microwave thermotherapy, "Prostatic Urethral Lift", "Transurethral Resection", or laser) or other surgical interventions of the prostate.
✕. Undergone a prostate biopsy within 60 days prior to the scheduled treatment date or has an imminent need for surgery.
✕. Verified acute bacterial prostatitis within last 12 months documented by culture.
✕. Active or history of epididymitis within the past 3 months.
✕. Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the Rezūm device.
✕. Diagnosed bladder, urethral or ureteral stones or active stone passage in the past 6 months, provided that stones that are known to be in the kidney and have been stable for a period exceeding 3 months are permissible.
✕
What they're measuring
1
Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS)
Timeframe: 6 Months
2
Number of Participants With Post Procedure Device Related Serious Complications