Promising prostate device trial halted after just one patient

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants must meet all inclusion criteria to participate in this study. 1. Males aged 45 years of age or older 2. IPSS score of 13 or higher 3. Eligible uroflow with unadjusted or adjusted peak flow rate of equal to or less than 13ml/sec with a corresponding: 1. voided volume of at least 100 ml, and, 2. Post Void Residual (PVR) of 250 ml or less 4. Prostate volume of 25-80 cm3, inclusive as measured by ultrasound or MRI 5. Prostatic sagittal length of 3.2 cm or greater, as measured by ultrasound or MRI 6. Prostatic transverse width of 3.5 cm or greater as measured by ultrasound or MRI 7. Prostatic anterior-posterior height of 2.5 cm or greater as measured by ultrasound or MRI 8. Participant must have the ability to understand and consent to participate in this study 9. Participant must be willing and able to participate in follow-up evaluations Exclusion Criteria: Participants meeting any of the exclusion criteria listed at baseline will be excluded from participation. 1. Outlet obstruction due to an enlarged middle lobe or significant central gland of the prostate 2. Significant transverse asymmetry of prostatic lateral lobes 3. Participant has an implantable pacemaker or cardiac defibrillator 4. Participant has a penile implant 5. History or current diagnosis of prostate cancer or bladder cancer 6. Active urinary tract infection (UTI) (Note: participant can be enrolled if the UTI is treated and followed with a negative urine test result) 7. Neurogenic, decompensated, or atonic bladder 8. Overactive bladder in the absence of prostatic obstruction 9. Current, recurrent (two or more) urethral strictures or muscle spasms that prevent insertion of the catheter 10. Bleeding disorders or takes anticoagulation medications unless anti-platelet medication has been discontinued for at least 7 days prior to treatment (Participants are allowed to delay or repeat screening to fulfil this requirement) 11. Previous rectal surgery other than haemorrhoidectomy 12. Previous radical pelvic surgery or pelvic irradiation 13. Interest in maintaining fertility 14. Previous surgery or minimally invasive procedure(s) to treat symptomatic BPH 15. Use of Alpha blocker for the treatment of BPH within 14 days of treatment date. (Participants are allowed to delay or repeat screening to fulfil this requirement) 16. 5-ARI (5-alpha-reductase inhibitor), (an enzyme inhibitor) use within 3 months of treatment date (Participants are allowed to delay screening to fulfil this requirement) 17. Concomitant bladder stones 18. History of other diseases or conditions causing voiding dysfunction 19. Current medication affecting bladder function 20. Known allergy to nickel 21. Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months 22. History of medical, surgical, or other conditions that, in the opinion of the investigator, would limit study participation