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Robot takes on prostate surgery: new study tests precision tool for BPH relief

NCT ID NCT06668142

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

45 years and older

Sex

Male participants only

Healthy volunteers

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

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.

  1. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hospital Clínico de la Universidad de Chile

    RECRUITING

    Santiago, Santiago Metropolitan, 8380453, Chile

  • Tauranga Urology Research Limited

    RECRUITING

    Tauranga, New Zealand

  • Universidad Catolica de Chile

    RECRUITING

    Santiago, Santiago Metropolitan, 8320165, Chile

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