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โ† Trials
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A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)

RecruitingNAAges 45 Years - anyMaleAndromeda Surgical
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In plain words

What the trial is, and whether it could suit you

Robotic assisted surgery for benign prostatic hyperplasia (BPH)

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male 2. Subject has diagnosis of lower urinary tract symptoms and/or urinary retention due to benign prostatic enlargement causing bladder outlet obstruction, 3. Subject is able and willing to comply with all the assessments of the study, 4. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the informed consent form, 5. โ‰ฅ 45 years of Age, 6. Prostate volume 40 - 120 cc by transrectal ultrasound (TRUS), magnetic resonance imaging (MRI), or computed tomography (CT), measured within one year prior to procedure, 7. The subject is indicated for undergoing HoLEP procedure Exclusion Criteria: 1. Urethral stricture, meatal stenosis, or bladder neck contracture - either current or recurrent, 2. History of prostate cancer or current/suspected bladder cancer, 3. Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds, 4. History of other diseases causing voiding dysfunction including urinary retention (e.g., diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.), 5. Subjects with overactive bladder in the absence of benign prostatic obstruction as determined by the investigator, 6. Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is treated) 7. Previous pelvic irradiation or radical pelvic surgery, 8. Previous prostate surgery, including enucleation, resection, vaporization, thermotherapy, ablation, stenting, or prostatic urethral lift, 9. Inability to stop taking anticoagulants for at least 3 days prior to the procedure or antiplatelets and/or coumadin for at least 5 days prior to the procedure (Note: low dose aspirin therapy is permitted), 10. Any severe illness that would prevent complete study participation or confound study results. 11. Bleeding tendency disorders, 12. Future fertility concerns, 13. Subject has any other disease or condition(s) that would interfere with completion of the study and follow-up assessments, would increase risks of the procedure, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect outcomes, 14. Concomitant participation in another interventional study
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What it tests

  • Beacon Platform
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Where

3 sites
Universidad Catolica de Chile
Santiago, Chile
Hospital Clรญnico de la Universidad de Chile
Santiago, Chile
Tauranga Urology Research Limited
Tauranga, New Zealand
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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