Robot takes on prostate surgery: new study tests precision tool for BPH relief
NCT ID NCT06668142
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new robotic system to help surgeons remove extra prostate tissue in men with an enlarged prostate (BPH). The goal is to see if the robot can safely and effectively ease urinary symptoms. About 54 men will take part, and the main focus is on how many surgeries are completed without switching to standard methods and how many serious side effects occur.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Clínico de la Universidad de Chile
RECRUITINGSantiago, Santiago Metropolitan, 8380453, Chile
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Tauranga Urology Research Limited
RECRUITINGTauranga, New Zealand
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Universidad Catolica de Chile
RECRUITINGSantiago, Santiago Metropolitan, 8320165, Chile
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Laser prostate surgery that spares ejaculation put to a Five-Year test
- Virtual basket laser mode put to the test for faster prostate surgery
- Steam therapy vs. surgery: can a less invasive fix help men with blocked urine flow?
- Listening to patients: a new way to guide prostate treatment?
- A surgical twist that could save ejaculation during prostate surgery
- Water jet surgery: a new wave for prostate relief?