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

Study Overview
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Brief Summary
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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

Official Title
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Evaluation of the Performance of a Robotic Flexible Ureteroscopy (ILY) in Laser Treatment of Nephrolithiasis in the Upper Urinary Tract

Conditions
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Lithiasis, Urinary

Intervention / Treatment
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* Device: ILY robotic flexible ureteroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: flexible ureteroscopy<br> | Device: ILY robotic flexible ureteroscopy<br>* fragmentation of nephrolithiasis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of procedures performed entirely using the telemanipulator |  | end of study: 3 months | 
| Number of procedures where the surgeon had to switch to manual mode or dedock the device |  | end of study: 3 months | 
| If telemanipulator remained stable during procedure | Yes/no | end of procedure; less than 2 hours | 
| Time of procedure |  | end of procedure; less than 2 hours | 
| Docking time | time between docking of device and use of gamepad | end of procedure; less than 2 hours | 
| Time taken to track kidney stones |  | end of procedure; less than 2 hours | 
| Time taken for complete exploration of renal cavities |  | end of procedure; less than 2 hours | 
| Laser fragmentation time |  | end of procedure; less than 2 hours | 
| Speed of fragmentation | mm3/minute | end of procedure; less than 2 hours | 
| Any joint pain strain experienced by the surgeon before and after intervention | binary yes/no | end of procedure; less than 2 hours | 
| Satisfaction of surgeon in using the device | Custom-made questionnaire with 3 sections measuring: ease of use, ergonomics in exploration of renal cavities and stability during fragmentation of laser | end of procedure; less than 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the rate of intra-operative complications during procedure |  | end of procedure; less than 2 hours | 
| Describe the rate of intra-operative complications |  | 1 month | 
| Integrity of the ureroscope at the end of the procedure | binary yes/no | end of procedure; less than 2 hours |