Lithiasis, Urinary
Conditions
Brief 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
Interventions
DEVICEILY robotic flexible ureteroscopy
fragmentation of nephrolithiasis
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of surgeon in using the device | end of procedure; less than 2 hours | Custom-made questionnaire with 3 sections measuring: ease of use, ergonomics in exploration of renal cavities and stability during fragmentation of laser |
| Laser fragmentation time | end of procedure; less than 2 hours | — |
| Speed of fragmentation | end of procedure; less than 2 hours | mm3/minute |
| Any joint pain strain experienced by the surgeon before and after intervention | end of procedure; less than 2 hours | binary yes/no |
| If telemanipulator remained stable during procedure | end of procedure; less than 2 hours | Yes/no |
| Time of procedure | end of procedure; less than 2 hours | — |
| 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 | — |
| Docking time | end of procedure; less than 2 hours | time between docking of device and use of gamepad |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Describe the rate of intra-operative complications | 1 month | — |
| Integrity of the ureroscope at the end of the procedure | end of procedure; less than 2 hours | binary yes/no |
| Describe the rate of intra-operative complications during procedure | end of procedure; less than 2 hours | — |
Countries
France
Outcome results
None listed