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

Launched by ANDROMEDA SURGICAL · Oct 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new robotic-assisted surgery tool called the Beacon Platform, used during a procedure called Holmium Laser Enucleation of the Prostate (HoLEP). This surgery helps men who have an enlarged prostate, a common condition called benign prostatic hyperplasia (BPH), which can cause problems with urination like difficulty starting or emptying the bladder. The study aims to see how well this robotic system works in helping doctors perform the surgery.

Men aged 45 and older who have symptoms from an enlarged prostate and meet specific criteria—such as having a prostate size between 40 and 120 cubic centimeters—may be eligible. Participants need to be willing to follow the study steps and give informed consent. The trial excludes men with certain other urinary or prostate conditions, recent infections, or those who have had previous prostate surgeries. If you join, you can expect to undergo the HoLEP procedure using the Beacon robotic platform and be monitored to see how well the surgery works and how safe it is. This study is currently recruiting, so if you or a family member think you might qualify, it’s a good idea to talk with your doctor about it.

Gender

MALE

Eligibility criteria

• 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. ≥ 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