RecruitingNot Applicable

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

Chile, New Zealand54 participantsStarted 2024-12-12

Plain-language summary

Robotic assisted surgery for benign prostatic hyperplasia (BPH)

Age range45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male
✓. Subject has diagnosis of lower urinary tract symptoms and/or urinary retention due to benign prostatic enlargement causing bladder outlet obstruction,
✓. Subject is able and willing to comply with all the assessments of the study,
✓. 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,
✓. ≥ 45 years of Age,
✓. Prostate volume 40 - 120 cc by transrectal ultrasound (TRUS), magnetic resonance imaging (MRI), or computed tomography (CT), measured within one year prior to procedure,
✓. The subject is indicated for undergoing HoLEP procedure

✕. Urethral stricture, meatal stenosis, or bladder neck contracture - either current or recurrent,
✕. History of prostate cancer or current/suspected bladder cancer,
✕. Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds,
✕. History of other diseases causing voiding dysfunction including urinary retention (e.g., diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.),
✕. Subjects with overactive bladder in the absence of benign prostatic obstruction as determined by the investigator,
✕. Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is treated)
✕. Previous pelvic irradiation or radical pelvic surgery,
✕. Previous prostate surgery, including enucleation, resection, vaporization, thermotherapy, ablation, stenting, or prostatic urethral lift,

Number of Participants Successfully Completing Robot-Assisted HoLEP (Enucleation and Morcellation) Without Conversion

Timeframe: During the procedure.

Number of subjects with adverse events ( Clavien-Dindo Grade 3a or higher )

Timeframe: From procedure date to 30 days

NCT IDNCT06668142

SponsorAndromeda Surgical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-30

Rami Abukhalil, MD. MPH

Who can participate

Age range45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male
✓. Subject has diagnosis of lower urinary tract symptoms and/or urinary retention due to benign prostatic enlargement causing bladder outlet obstruction,
✓. Subject is able and willing to comply with all the assessments of the study,
✓. 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,
✓. ≥ 45 years of Age,
✓. Prostate volume 40 - 120 cc by transrectal ultrasound (TRUS), magnetic resonance imaging (MRI), or computed tomography (CT), measured within one year prior to procedure,
✓. The subject is indicated for undergoing HoLEP procedure

✕. Urethral stricture, meatal stenosis, or bladder neck contracture - either current or recurrent,
✕. History of prostate cancer or current/suspected bladder cancer,
✕. Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds,
✕. History of other diseases causing voiding dysfunction including urinary retention (e.g., diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.),
✕. Subjects with overactive bladder in the absence of benign prostatic obstruction as determined by the investigator,
✕. Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is treated)
✕. Previous pelvic irradiation or radical pelvic surgery,
✕. Previous prostate surgery, including enucleation, resection, vaporization, thermotherapy, ablation, stenting, or prostatic urethral lift,