WithdrawnNot Applicable

Evaluation of the Performance of a Robotic Flexible Ureteroscopy (ILY) in Laser Treatment of Nephrolithiasis

Stopped: No actual DM

France0Started 2018-10

Plain-language summary

In this pilot study, we wish to evaluate the performance of a robotic flexible ureteorscopy (ILY) in the treatment of nephrolithiasis in the superior excretory system

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

Inclusion Criteria: * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan * The patient is at least 18 years old * The patient has a single kidney stone in the calyx or the pelvis between 5 and 15mm something to do with a JJ probe * Patient has an indication for in situ lithotripsy by supply ureteroscopy Exclusion Criteria: * The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study * The patient is under safeguard of justice or state guardianship * The subject refuses to sign the consent * It is impossible to give the subject informed information * The patient is pregnant or breastfeeding * Patient treated with anticoagulants * Documented untreated urinary infection within the previous 48 hours

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of procedures performed entirely using the telemanipulator

Timeframe: end of study: 3 months

Number of procedures where the surgeon had to switch to manual mode or dedock the device

Timeframe: end of study: 3 months

If telemanipulator remained stable during procedure

Timeframe: end of procedure; less than 2 hours

Time of procedure

Timeframe: end of procedure; less than 2 hours

Docking time

Timeframe: end of procedure; less than 2 hours

Time taken to track kidney stones

Timeframe: end of procedure; less than 2 hours

Time taken for complete exploration of renal cavities

Timeframe: end of procedure; less than 2 hours

Trial details

NCT IDNCT03638336

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01

View on ClinicalTrials.gov More Lithiasis, Urinary trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

What they're measuring

Number of procedures performed entirely using the telemanipulator

Timeframe: end of study: 3 months

Number of procedures where the surgeon had to switch to manual mode or dedock the device

Timeframe: end of study: 3 months

If telemanipulator remained stable during procedure

Timeframe: end of procedure; less than 2 hours

Time of procedure

Timeframe: end of procedure; less than 2 hours

Docking time

Timeframe: end of procedure; less than 2 hours

Time taken to track kidney stones

Timeframe: end of procedure; less than 2 hours

Time taken for complete exploration of renal cavities

Timeframe: end of procedure; less than 2 hours