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Robots tackle kidney stones in new surgical trial

NCT ID NCT06330701

Disease control Sponsor: Auris Health, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a robot-assisted system called MONARCH to remove kidney stones through a small incision in the back. Fifteen adults with stones larger than 1 cm took part. The goal was to see if the robot could safely complete the procedure and clear the stones. Results showed the procedure was successful in most cases, with many participants being stone-free after 30 days.

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

15 people

The number who actually took part.

Started

Jan 2024

Finished

Mar 2025

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

22 years and older

Sex

Anyone

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: * Simple renal caliceal and/or pyelo stone(s) with stone burden =\> 1 cm, identified on CT scan, and appropriate for PCNL treatment according to AUA guidelines * Normal upper tract anatomy, amenable to PCNL and ureteroscopy * Participants with a percutaneous tract length \< 15 cm as measured by the estimation of the skin to stone or skin to appropriate calyx for treatment through a CT scan * Participant is an appropriate candidate for a mini-PCNL based on the clinical guidelines and investigator assessment. Exclusion Criteria: Pre-Procedure:Exclusion Criteria: * Any medical or physical condition/limitation that would contra-indicate a conventional ureteroscopy or PCNL in the supine position (e.g., atypical interposition of visceral organs (bowel, spleen, or liver)) * Expected additional procedure, or participation in any clinical trial, from 30 days prior to the study procedure and throughout the duration of the study, which might impact this study's results * A solitary functioning kidney * Female participants who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test * Presence of ureteral impacted stones Intra-Procedure Exclusion Criteria: \- Any presenting condition discovered intra-procedurally that in the opinion of the investigator would make participating in this study not in the participant's best interest.

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Conditions

The condition(s) this trial relates to.

Kidney Calculi nephrolithiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney calculi

Contacts and locations

Locations

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • UW School of Medicine and Public Health

    Madison, Wisconsin, 53705, United States

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